Ovarian CarcinomaNCT04251052
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
A study testing Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy and Biospecimen Collection in people with Ovarian Carcinoma, run by NRG Oncology at 574 sites in 3 countries.
Trial summary
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,956 participants
- Where
- 574 sitesin 3 countries
- Study dates
- 1 Sep 2020to 30 Jun 2047
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals 35-50 years of age, inclusive
- Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
- At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
- Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
- Patients may be premenopausal or menopausal
- Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI and CA-125 within 180 days of registration
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future
Who cannot join
- Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
- Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
- Patients medically unfit for the planned surgical procedure
- Patients with abnormal screening tests (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
- An abnormal pelvic ultrasound (or pelvic MRI) is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary
- An abnormal CA-125 is defined as a level > 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals
Trial locations and contacts
574 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
310 sites in 3 countries
United States300 sites, 252 recruiting
- Active, not recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
- Active, not recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
- Active, not recruiting
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
- Active, not recruiting
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
- Active, not recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Dan S. Zuckerman
- Not yet recruiting
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
Mark S. Shahin, Mark.Shahin@jefferson.edu
Mark S. Shahin
- Suspended
Cleveland Clinic Akron General
Akron, Ohio, 44307
- Recruiting
Women's Cancer Care Associates LLC
Albany, New York, 12208
Site Public Contact, 518-458-1390, jbarlin@womenscancercareassociates.com
Emese Zsiros
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Carolyn Y. Muller
- Active, not recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
- Recruiting
Aultman Alliance Community Hospital
Alliance, Ohio, 44601
Site Public Contact, 330-363-1250
Sunitha Vemulapalli
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Dan S. Zuckerman
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Christine Garcia
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com
Amy L. Alexander
- Recruiting
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816
Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com
Amy L. Alexander
- Recruiting
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Susan C. Modesitt
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Susan C. Modesitt
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Susan C. Modesitt
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Susan C. Modesitt
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Guilherme Henrique C. Cantuaria
- Suspended
Augusta University Medical Center
Augusta, Georgia, 30912
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Lindsay Brubaker
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Ismail Mert
- Recruiting
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 954-461-2180
Matthew P. Schlumbrecht
- Active, not recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Active, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Ismail Mert
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Kara C. Long Roche
- Recruiting
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
South Shore University Hospital
Bay Shore, New York, 11706
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Sarah K. Lynam
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223, achapman1@peacehealth.org
Dan S. Zuckerman
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Dan S. Zuckerman
- Suspended
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Emily N. Prendergast
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Saint Vincent Healthcare
Billings, Montana, 59101
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Megan Petersen
- Recruiting
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Site Public Contact, 800-648-6274
Megan Petersen
- Recruiting
Intermountain Health West End Clinic
Billings, Montana, 59106
Site Public Contact, 406-238-6685
Megan Petersen
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Charles A. Leath
- Recruiting
Carle BroMenn Outpatient Center
Bloomington, Illinois, 61704
Site Public Contact, 800-446-5532, Research@Carle.com
Georgina Cheng
- Recruiting
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Site Public Contact, 912-819-5704, underberga@sjchs.org
Sarah E. Gill
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Site Public Contact, 617-667-9925
Nicole P. Chappell
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Florida Cancer Specialists - Bradenton Cancer Center
Bradenton, Florida, 34205
Site Public Contact, 239-274-9930, clinicaltrials@flcancer.com
Beverly Long
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Krista S. Pfaendler
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Island Gynecologic Oncology
Brightwaters, New York, 11718
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
Keck Medicine of USC Buena Park
Buena Park, California, 90621
Site Public Contact, 714-522-0908
Koji Matsuo
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Dan S. Zuckerman
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Site Public Contact, 406-723-2621
Megan Petersen
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Site Public Contact, 856-325-6757
David P. Warshal
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Sunitha Vemulapalli
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Site Public Contact, 317-278-5632, iutrials@iu.edu
Jessica E. Parker
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Recruiting
Duke Cancer Center Cary
Cary, North Carolina, 27518
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Haley Moss
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Michael S. Guy
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Dan S. Zuckerman
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Olivia D. Lara
- Recruiting
Geauga Hospital
Chardon, Ohio, 44024
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Sarah K. Lynam
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Maggie Westfal
- Recruiting
West Virginia University Charleston Division
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944
Stephen H. Bush
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Kari L. Ring
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Emma Barber
- Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Alexander C. Cohen
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Sarah Werner
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Kathryn A. Mills
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Ismail Mert
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Amanda L. Jackson
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Morton Plant Hospital
Clearwater, Florida, 33756
Site Public Contact, 855-314-8646
Robert C. Gabordi
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Sarah K. Lynam
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Site Public Contact, 216-778-7559, ababal@metrohealth.org
Kimberly E. Resnick
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Lindsey Beffa
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Lindsey Beffa
- Suspended
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Lindsay Brubaker
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Lindsay Brubaker
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Floor Backes
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Kara C. Long Roche
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Dan S. Zuckerman
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Site Public Contact, 305-243-2647
Matthew P. Schlumbrecht
- Recruiting
Baptist Health Corbin
Corbin, Kentucky, 40701
Site Public Contact, 859-523-1934
Hope Cottrill
- Recruiting
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
Site Public Contact, 712-322-4136
Brent J. Tierney
- Recruiting
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
Site Public Contact, 402-354-7939, kathryn.bartz@nmhs.org
Brent J. Tierney
- Recruiting
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, 51503
Site Public Contact, 402-354-5892, Liza.brandes@nmhs.org
Brent J. Tierney
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Kathryn A. Mills
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Ismail Mert
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Withdrawn
Parkland Memorial Hospital
Dallas, Texas, 75235
- Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Recruiting
Danbury Hospital
Danbury, Connecticut, 06810
Site Public Contact, 833-223-4732
Linus T. Chuang
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Georgina Cheng
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Michael S. Guy
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Michael S. Guy
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Dana Zakalik
- Recruiting
Emory Decatur Hospital
Decatur, Georgia, 30033
Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org
Susan C. Modesitt
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Matthew P. Schlumbrecht
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Emma Barber
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Suspended
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166
Site Public Contact, kginnity@med.miami.edu
Matthew P. Schlumbrecht
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Ismail Mert
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Mihae Song
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Christine Garcia
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Haley Moss
- Active, not recruiting
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Dan S. Zuckerman
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Georgina Cheng
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Ismail Mert
- Suspended
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Site Public Contact, 630-758-5460, Jrohde@emhc.org
Samir D. Undevia
- Recruiting
Florida Cancer Specialists-Englewood
Englewood, Florida, 34223
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Beverly Long
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Gustavo C. Rodriguez
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Dan S. Zuckerman
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Rebecca D. Kaltman
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Rebecca D. Kaltman
- Recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Andrea D. Jewell
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Rebecca D. Kaltman
- Suspended
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
- Recruiting
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
Site Public Contact, 248-551-7695
Dana Zakalik
- Suspended
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
- Recruiting
Northwell Health Physician Partners at Flushing
Flushing, New York, 11354
Site Public Contact, 718-559-3600, nhppflushing@northwell.edu
Marina Frimer
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Lindsay Brubaker
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Lindsay Brubaker
- Suspended
GenesisCare USA - FGO
Fort Myers, Florida, 33905
- Suspended
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
- Suspended
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Michael S. Guy
- Recruiting
Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee, 37067
Site Public Contact, 800-811-8480
Alaina J. Brown
- Recruiting
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067
Site Public Contact, 800-811-8480
Alaina J. Brown
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Christine Garcia
- Suspended
Fresno Cancer Center
Fresno, California, 93720
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Christine Garcia
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Christine Garcia
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Carlton L. Schwab
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010, cancer-center@ufl.edu
David A. Iglesias
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Raanan Alter
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Active, not recruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Gustavo C. Rodriguez
- Active, not recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
- Active, not recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
- Recruiting
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Site Public Contact, 574-364-2973, cccois@goshenhealth.com
Pamela J. Stone
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Active, not recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Lindsay Brubaker
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Michael S. Guy
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Jeffrey W. Elder
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Jeffrey W. Elder
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Mitchell B. Clark
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Carlton L. Schwab
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Kara C. Long Roche
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Site Public Contact, 860-545-5363
Marguerite (Meg) L. Palisoul
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Ismail Mert
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Shaina Bruce
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Gustavo C. Rodriguez
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Site Public Contact, 720-848-0650
Lindsay Brubaker
- Active, not recruiting
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521
- Active, not recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
- Active, not recruiting
Island Urology
Honolulu, Hawaii, 96813
- Active, not recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
- Active, not recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
- Active, not recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
- Active, not recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
- Active, not recruiting
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
- Active, not recruiting
Kuakini Medical Center
Honolulu, Hawaii, 96817
- Active, not recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
- Active, not recruiting
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
- Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Site Public Contact, 808-432-5195, shelley.a.clark@kp.org
Christine Garcia
- Active, not recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
- Recruiting
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org
Dan S. Zuckerman
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Claire Hoppenot
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Claire Hoppenot
- Recruiting
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
Site Public Contact, 713-792-3245
Joseph A. Lucci
- Recruiting
Huntington Hospital
Huntington, New York, 11743
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Site Public Contact, 626-256-4673
Mihae Song
- Recruiting
Keck Medicine of USC Huntington Beach
Huntington Beach, California, 92648
Site Public Contact, 714-861-1000, karenn@pacshoresoncology.com
Koji Matsuo
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Jessica E. Parker
- Active, not recruiting
Community Cancer Center North
Indianapolis, Indiana, 46256
- Recruiting
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Site Public Contact, 317-338-2194, research@stvincent.org
Megan E. Buechel
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
David P. Bender
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Site Public Contact, 877-467-3411
Mihae Song
- Recruiting
Kaiser Permanente-Irvine
Irvine, California, 92618
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Scott E. Lentz
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Dan S. Zuckerman
- Recruiting
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Site Public Contact, 412-359-3043, ddefazio@wpahs.org
Sarah M. Crafton
- Recruiting
Jersey City Medical Center
Jersey City, New Jersey, 07302
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Eugenia Girda
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Andrea D. Jewell
- Recruiting
Fred and Pamela Buffett Cancer Center - Kearney
Kearney, Nebraska, 68845
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Kerry J. Rodabaugh
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Dan S. Zuckerman
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Dan S. Zuckerman
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Emma Barber
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Mihae Song
- Recruiting
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Sarah H. Kim
- Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Sarah H. Kim
- Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
Site Public Contact, 702-851-4672
Nicola M. Spirtos
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Ilana Cass
- Suspended
Beebe Medical Center
Lewes, Delaware, 19958
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Site Public Contact, 859-260-6425
Hope Cottrill
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Ismail Mert
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Ismail Mert
- Active, not recruiting
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Heather R. Williams
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Site Public Contact, 973-322-5200
Eugenia Girda
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
J. R. Liu
- Suspended
Longmont United Hospital
Longmont, Colorado, 80501
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Dan S. Zuckerman
- Recruiting
Keck Medicine of USC Koreatown
Los Angeles, California, 90020
Site Public Contact, 213-388-0908
Koji Matsuo
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Scott E. Lentz
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Koji Matsuo
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Koji Matsuo
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Emily N. Prendergast
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Beth Y. Karlan
- Recruiting
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202
Site Public Contact, 502-629-2500, cancerresearch@nortonhealthcare.org
Monica H. Vetter
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Site Public Contact, 502-897-8592, Cbcresearch@bhsi.com
Hope Cottrill
- Recruiting
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, 40207
Site Public Contact, 502-629-3465
Monica H. Vetter
- Recruiting
Norton Audubon Hospital and Medical Campus
Louisville, Kentucky, 40217
Site Public Contact, 502-629-3465
Monica H. Vetter
- Recruiting
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky, 40241
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Monica H. Vetter
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Lindsay Brubaker
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Lisa M. Barroilhet
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Lisa M. Barroilhet
- Active, not recruiting
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville, Kentucky, 42431
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Site Public Contact, 516-734-8896
Marina Frimer
- Recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Minnesota Oncology - Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1572, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
OhioHealth Marion General Hospital
Marion, Ohio, 43302
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine E. Clements
- Recruiting
West Jefferson Medical Center
Marrero, Louisiana, 70072
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Tara Castellano
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Elmer G. Lehman
- Recruiting
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Krista S. Pfaendler
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Georgina Cheng
- Recruiting
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Lindsey Beffa
- Recruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Sarah K. Lynam
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, 33136
Site Public Contact, 305-243-3975
Matthew P. Schlumbrecht
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Matthew P. Schlumbrecht
- Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Site Public Contact, 305-243-2647
Matthew P. Schlumbrecht
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Kara C. Long Roche
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
William H. Bradley
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Ismail Mert
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Marina Stasenko
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Jessica A. Thomes Pepin
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Site Public Contact, 612-624-2620
Deanna G. Teoh
South Korea8 sites, 5 recruiting
- Suspended
Keimyung University-Dongsan Medical Center
Dalseo-gu, Daegu, 42601
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, 14347
Site Public Contact, 82 2-1811-7800
Hyun Jin Choi
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, 463-707
Site Public Contact, 82-2-2072-2890
Dong Hoon Suh
- Suspended
Samsung Changwon Hospital
Seoul, Gyeongsangnam-do, 51353
- Recruiting
Asan Medical Center
Seoul, 05505
Site Public Contact, irbksh@amc.seoul.kr
Shin Wha Lee
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
Site Public Contact, 82-2-2019-3600
Jae-Hoon Kim
- Recruiting
Ewha Woman's University Mokdong Hospital
Seoul, 07985
Site Public Contact, 82 2-2650-5114
Mikyung Kim
- Suspended
Yonsei University Health System-Severance Hospital
Seoul, 120-752
Canada2 sites, 1 recruiting
- Suspended
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Janice S. Kwon
About this study
Official title: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.
SECONDARY OBJECTIVES:
- To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm.
II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]) and sexual dysfunction (Female Sexual Function Index [FSFI]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.
III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale [IES]) in individuals who have undergone BLS, in comparison to BSO patients.
IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
- To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
EXPLORATORY OBJECTIVES:
- Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients).
II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.
III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.
TRANSLATIONAL RESEARCH OBJECTIVE:
- To bank tissue and blood biospecimens for future research.
OUTLINE: Patients choose between 1 of 2 groups.
GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.
GROUP II: Patients undergo bilateral salpingo-oophorectomy.
Patients in both groups also undergo a pelvic or transvaginal ultrasound or pelvic magnetic resonance imaging (MRI) during screening and blood sample collection throughout the trial.
After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.
- Conditions
- Ovarian Carcinoma
- Being tested
- Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy, Biospecimen Collection, Magnetic Resonance Imaging, Quality-of-Life Assessment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral SalpingectomyProcedure or surgery
Undergo bilateral salpingectomy
Bilateral Salpingectomy with OophorectomyProcedure or surgery
Also called bilateral salpingo-oophorectomy
Undergo bilateral salpingo-oophorectomy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo pelvic MRI
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Transvaginal UltrasoundProcedure or surgery
Also called transvaginal sonography, TVS, TVU
Undergo transvaginal ultrasound
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo pelvic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Group I (bilateral salpingectomy) | Experimental | Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial. Receives: Procedure: Bilateral Salpingectomy; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transvaginal Ultrasound; Procedure: Ultrasound Imaging |
| Group II (bilateral salpingo-oophorectomy) | Active comparator | Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial. Receives: Procedure: Bilateral Salpingectomy with Oophorectomy; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transvaginal Ultrasound; Procedure: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
Measured: Up to 20 years
Secondary outcomes (7)
Health-related quality of life (QOL)
Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Scores range from 0 to 76. Higher scores indicate better QOL for the FACT-ES and better functioning for the Female Sexual Function Index (FSFI) total score.
Measured: Up to 24 months post-surgery
Cancer distress
Will be measured by the Impact of Events Scale (IES). The total score can range from 0 to 88, with higher scores indicating a greater impact of the event.
Measured: Up to 24 months post-surgery
Medical decision making
Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9) and, Decisional Regret Scale. The SDM-Q-9 total score and Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race. A similar model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status. Minimum score of 0 and a maximum score of 45. A higher score indicates a greater level of perceived shared decision-making in a consultation.
Measured: Up to 24 months post-surgery
Incidence of adverse events
Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the bilateral salpingo-oophorectomy arm using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.
Measured: Up to 20 years
Estrogen deprivation symptoms (pre-menopaused patients only)
Will be measured by the FACT-ES. The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Scores range from 0 to 76. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score. Models will also include hormonal therapy as a covariate.
Measured: Up to 24 months post-surgery
Sexual dysfunction (pre-menopausal patients only)
Will be measured by the FSFI. Scores range from 0 to 36. Higher scores indicate better functioning for the FSFI total score.
Measured: Up to 24 months post-surgery
Menopausal symptoms (pre-menopausal patients only)
Will be measured by the Menopausal Symptom Checklist (MSCL). Models will also include hormonal therapy as a covariate. The MSCL total score and individual items will be compared between groups using the t-test and Wilcoxon test, respectively. The change from baseline in total score will be compared between groups at each follow-up time point. The change form baseline in the 3 items not included in the subscale scores will be compared between groups using the Wilcoxon test at each follow-up time point.
Measured: Up to 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2047 (estimated)
- Study completion30 Jun 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized prospective trial to determine if bilateral salpingectomy (BLS) is non-inferior to bilateral salpingo-oophorectomy (BSO) in terms ovarian, primary peritoneal, and fallopian tube cancer risk among gBRCA1m carriers between 35 and 50 years old. Individuals choose the treatment they want to receive in collaboration with their physician(s).
- Masking
- None (open label)
- Enrolment
- 1,956 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn P Pennington, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251052
- Sponsor's protocol ID
- NRG-CC008
- Other IDs
- NCI-2019-07791, NRG-CC008, NRG-CC008, NRG-CC008, UG1CA189867
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7.
PubMed 39509704
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
- ClinicalTrials.gov ID
- NCT04251052
- Acronym / sponsor ID
- NRG-CC008
- Conditions
- Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,956 participants (estimated)
- Lead sponsor
- NRG OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2047 (estimated)
- Study completion
- 30 Jun 2047 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
Detailed description
PRIMARY OBJECTIVE:
- To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.
SECONDARY OBJECTIVES:
- To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm.
II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]) and sexual dysfunction (Female Sexual Function Index [FSFI]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.
III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale [IES]) in individuals who have undergone BLS, in comparison to BSO patients.
IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
- To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
EXPLORATORY OBJECTIVES:
- Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients).
II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.
III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.
TRANSLATIONAL RESEARCH OBJECTIVE:
- To bank tissue and blood biospecimens for future research.
OUTLINE: Patients choose between 1 of 2 groups.
GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.
GROUP II: Patients undergo bilateral salpingo-oophorectomy.
Patients in both groups also undergo a pelvic or transvaginal ultrasound or pelvic magnetic resonance imaging (MRI) during screening and blood sample collection throughout the trial.
After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized prospective trial to determine if bilateral salpingectomy (BLS) is non-inferior to bilateral salpingo-oophorectomy (BSO) in terms ovarian, primary peritoneal, and fallopian tube cancer risk among gBRCA1m carriers between 35 and 50 years old. Individuals choose the treatment they want to receive in collaboration with their physician(s).
| Arm | Type | Receives |
|---|---|---|
| Group I (bilateral salpingectomy) | Experimental | Procedure: Bilateral Salpingectomy, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transvaginal Ultrasound, Procedure: Ultrasound ImagingPatients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial. |
| Group II (bilateral salpingo-oophorectomy) | Active comparator | Procedure: Bilateral Salpingectomy with Oophorectomy, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transvaginal Ultrasound, Procedure: Ultrasound ImagingPatients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Individuals 35-50 years of age, inclusive
- Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
- At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
- Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
- Patients may be premenopausal or menopausal
Key exclusion criteria (6 listed)
- Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
- Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
- Patients medically unfit for the planned surgical procedure
- Patients with abnormal screening tests (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral SalpingectomyUndergo bilateral salpingectomy | Procedure or surgery | Group I (bilateral salpingectomy) |
| Bilateral Salpingectomy with OophorectomyAlso: bilateral salpingo-oophorectomyUndergo bilateral salpingo-oophorectomy | Procedure or surgery | Group II (bilateral salpingo-oophorectomy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo pelvic MRI | Procedure or surgery | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
| Questionnaire AdministrationAncillary studies | Other | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
| Transvaginal UltrasoundAlso: transvaginal sonography, TVS, TVUUndergo transvaginal ultrasound | Procedure or surgery | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
| Ultrasound ImagingAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo pelvic ultrasound | Procedure or surgery | Group I (bilateral salpingectomy), Group II (bilateral salpingo-oophorectomy) |
Primary outcome
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Time frame: Up to 20 years
Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
7 secondary outcomes
Health-related quality of life (QOL)
Time frame: Up to 24 months post-surgery
Cancer distress
Time frame: Up to 24 months post-surgery
Medical decision making
Time frame: Up to 24 months post-surgery
Incidence of adverse events
Time frame: Up to 20 years
Estrogen deprivation symptoms (pre-menopaused patients only)
Time frame: Up to 24 months post-surgery
Sexual dysfunction (pre-menopausal patients only)
Time frame: Up to 24 months post-surgery
Menopausal symptoms (pre-menopausal patients only)
Time frame: Up to 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 39509704Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anchorage Associates in Radiation Medicine
Anchorage, United States
Alaska Breast Care and Surgery LLC
Anchorage, United States
Kathryn P Pennington principal investigator
NRG Oncology
574 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy and Biospecimen Collection in people with Ovarian Carcinoma, run by NRG Oncology at 574 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 574 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers (time frame: Up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.