Borderline Ovarian Clear Cell TumorNCT00897442
Collecting Tumor Samples From Patients With Gynecological Tumors
An observational study of Borderline Ovarian Clear Cell Tumor and Borderline Ovarian Serous Tumor, run by Gynecologic Oncology Group at 187 sites in United States.
Trial summary
This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Borderline Ovarian Clear Cell Tumor, Borderline Ovarian Serous Tumor, Cervical Adenocarcinoma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 275 participants
- Where
- 187 sitesUnited States
- Study dates
- Jun 1992to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Gynecological Tumors
Who may be able to join
- Any of the following:
- Patients who have had gynecologic tissue removed during surgery to diagnosis, treat, monitor, and/or prevent primary, persistent, or recurrent gynecologic cancer of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, meeting at least one of the following criteria:
- Group A: Women who underwent surgery, were diagnosed with a primary gynecologic malignancy of the ovary, cervix, uterine corpus, or vulva, and have primary tumor, normal tissue, and blood available for submission for this protocol
- Patients with ovarian cancer including all stages, grades, and common epithelial cell types
- Invasive cancers and serous and mucinous borderline tumors of low malignant potential are allowed
- At least 1 gram of frozen primary tumor tissue must be submitted for this protocol for patients with FIGO stage III or IV epithelial ovarian cancer
Show all 27Show fewer
- Patients with an invasive malignancy of the cervix or uterine corpus including all stages, grades, and common cell types
- Patients with squamous cell carcinoma of the vulva
- Group B: Women who underwent surgery and were diagnosed with a rare gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, vulva, a gestational trophoblastic tumor, or a tumor arising in endometriosis, and have tumor tissue available for submission for this protocol
- Patients with a rare gynecologic malignancy of the ovary including malignant germ cell tumors; sex cord-stromal tumors; malignant mixed mesodermal tumors; clear cell, mucinous, small cell, or transitional cell carcinomas; malignant Brenner tumors; or borderline tumors of low malignant potential (except serous and mucinous)
- Patients with a rare gynecologic malignancy of the peritoneum, including primary peritoneal cancer or mesothelioma
- Patients with carcinoma of the fallopian tube
- Patients with a rare gynecologic malignancy of the cervix including verrucous, small cell, clear cell, serous, or adenoid cystic carcinomas; carcinoid tumors; malignant mixed mesodermal tumors; or leiomyosarcoma
- Patients with a rare gynecologic malignancy of the uterine corpus including leiomyosarcoma; malignant mixed mesodermal tumors; endometrial stromal sarcomas; smooth muscle tumors of unknown malignant potential; or clear cell or small cell carcinomas
- Patients with a rare gynecologic malignancy of the vagina including verrucous or clear cell carcinomas; melanoma; embryonal rhabdomyosarcoma; or endodermal sinus tumor
- Patients with a rare gynecologic malignancy of the vulva including verrucous carcinoma; melanoma; aggressive angiomyxoma; sarcoma; malignant Paget's disease; or Bartholin gland carcinoma
- Patients with a gestational trophoblastic tumor
- Patients with a tumor arising in endometriosis
- Group C: Women who underwent prophylactic oophorectomy and have at least 1 gram of ovarian tissue and blood available for submission for this protocol
- Group D: Women who underwent surgery to monitor or treat a persistent or recurrent gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, and have persistent or recurrent tumor, normal tissue, and blood available for submission for this protocol
- Concurrent primary cancers are allowed
- No benign cystic tumors of the ovary, including cystic epithelial tumors and mature cystic teratomas
- Prior cytotoxic chemotherapy allowed
- Prior hormonal therapy allowed
- Prior radiotherapy allowed
- Prior surgery allowed
- No more than 6 weeks after prior surgery
Who cannot join
None listed.
Trial locations and contacts
187 sites in 1 country.
187 sites in 1 country
United States187 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Akron General Medical Center
Akron, Ohio, 44307
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Our Lady Bellefonte Hospital
Ashland, Kentucky, 41101
Northside Hospital
Atlanta, Georgia, 30342
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Augusta University Medical Center
Augusta, Georgia, 30912
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
University Medical Center Brackenridge
Austin, Texas, 78701
The Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Woman's Hospital
Baton Rouge, Louisiana, 70817
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Parkland Memorial Hospital
Dallas, Texas, 75235
Zale Lipshy University Hospital
Dallas, Texas, 75235
Clements University Hospital
Dallas, Texas, 75390
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Danbury Hospital
Danbury, Connecticut, 06810
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Saint Elizabeth Medical Center South
Edgewood, Kentucky, 41017
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, 72703
Washington Regional Medical Center - Fayetteville
Fayetteville, Arkansas, 72703
Saint Francis Hospital
Federal Way, Washington, 98003
Hurley Medical Center
Flint, Michigan, 48502
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
University of Texas Medical Branch
Galveston, Texas, 77555-0565
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546
Gynecologic Oncology Network
Greenville, North Carolina, 27834
Pitt County Memorial Hosp Inc.
Greenville, North Carolina, 27834
East Carolina University
Greenville, North Carolina, 27858
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Hackensack University Medical CCOP
Hackensack, New Jersey, 07601
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Virginia Oncology Associates-Hampton
Hampton, Virginia, 23666
Hartford Hospital
Hartford, Connecticut, 06102
The Methodist Hospital System
Houston, Texas, 77030
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, 39216
University of Mississippi Medical Center
Jackson, Mississippi, 39216
East Tennessee State University
Johnson City, Tennessee, 37614-0054
Jupiter Medical Center
Jupiter, Florida, 33458
Keesler Medical Center
Kessler Air Force Base, Mississippi, 39534
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, 37917
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848
Saint Clare Hospital
Lakewood, Washington, 98499
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, 90806
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Marshfield Clinic
Marshfield, Wisconsin, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Winthrop University Hospital
Mineola, New York, 11501
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Meharry Medical College
Nashville, Tennessee, 37208
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Yale University
New Haven, Connecticut, 06520
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10029
Columbia University/Herbert Irving Cancer Center
New York, New York, 10032
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166
Capital Medical Center
Olympia, Washington, 98507
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Temple University Hospital
Philadelphia, Pennsylvania, 19140
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
Compass Oncology Rose Quarter
Portland, Oregon, 97227
Women and Infants Hospital
Providence, Rhode Island, 02905
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Memorial University Medical Center
Savannah, Georgia, 31404
Virginia Mason CCOP
Seattle, Washington, 98101
Virginia Mason Medical Center
Seattle, Washington, 98101
Pacific Gynecology Specialists
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307
University of Washington Medical Center
Seattle, Washington, 98195
CHRISTUS Highland Medical Center
Shreveport, Louisiana, 71105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307
Memorial Medical Center
Springfield, Illinois, 62781
Baystate Medical Center
Springfield, Massachusetts, 01199
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Saint Louis University Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Geisinger Medical Group
State College, Pennsylvania, 16801
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
Stony Brook University Medical Center
Stony Brook, New York, 11794
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342
MultiCare Allenmore Hospital
Tacoma, Washington, 98405
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Northwest NCI Community Oncology Research Program
Tacoma, Washington, 98405
Saint Joseph Medical Center
Tacoma, Washington, 98405
Multicare Health System
Tacoma, Washington, 98415
Scott and White Memorial Hospital
Temple, Texas, 76508
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Methodist West Hospital
West Des Moines, Iowa, 50266-7700
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
Diagnostic and Treatment Center
Weston, Wisconsin, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer
This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect gynecologic tissue and blood from participating Gynecologic Oncology Group (GOG) institutions.
II. To provide a repository for long-term storage of gynecologic tissue and blood that will be used in studies designed to better understand the molecular biology of gynecologic tumors.
III. To make available, through the GOG Tissue Bank, tissue and blood for proposed projects conducted by GOG and non-GOG investigators.
OUTLINE:
Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues.
- Conditions
- Borderline Ovarian Clear Cell Tumor, Borderline Ovarian Serous Tumor, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Ovarian Germ Cell Cancer, Sarcoma, Endometrial Stromal, Gestational Trophoblastic Disease, Mesothelioma, Malignant, Melanoma, Brenner Tumor, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biomarker sampling and analysis) | Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of gynecological tumor specimens and serum from patients at GOG institutions
Measured: Baseline
Create a repository for long-term storage of these specimens
Measured: Baseline
Make available tissue and blood for proposed projects
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 1992
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Ovarian Clear Cell TumorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Cibull, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897442
- Sponsor's protocol ID
- GOG-0136
- Other IDs
- NCI-2009-00577, GOG-136, CDR0000078647, GOG-0136, GOG-0136, U10CA180868
- Status last verified
- Oct 2016
- First submitted
- 9 May 2009
- Last updated
- 28 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer
- ClinicalTrials.gov ID
- NCT00897442
- Acronym / sponsor ID
- GOG-0136
- Conditions
- Borderline Ovarian Clear Cell Tumor, Borderline Ovarian Serous Tumor, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1992
- Primary completion
- Jan 2016 (actual)
- First posted
- 12 May 2009 (estimated)
- 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 laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer.
Detailed description
PRIMARY OBJECTIVES:
- To collect gynecologic tissue and blood from participating Gynecologic Oncology Group (GOG) institutions.
II. To provide a repository for long-term storage of gynecologic tissue and blood that will be used in studies designed to better understand the molecular biology of gynecologic tumors.
III. To make available, through the GOG Tissue Bank, tissue and blood for proposed projects conducted by GOG and non-GOG investigators.
OUTLINE:
Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biomarker sampling and analysis) | – | Other: Laboratory Biomarker AnalysisSnap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Gynecological Tumors
Key inclusion criteria (27 listed)
- Any of the following:
- Concurrent primary cancers are allowed
- No benign cystic tumors of the ovary, including cystic epithelial tumors and mature cystic teratomas
- Prior cytotoxic chemotherapy allowed
- Prior hormonal therapy allowed
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (biomarker sampling and analysis) |
Primary outcome
Collection of gynecological tumor specimens and serum from patients at GOG institutions
Time frame: Baseline
Create a repository for long-term storage of these specimens
Time frame: Baseline
Make available tissue and blood for proposed projects
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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. This study is not recruiting at the moment.
Michael Cibull principal investigator
NRG Oncology
187 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Ovarian Clear Cell Tumor and Borderline Ovarian Serous Tumor, run by Gynecologic Oncology Group at 187 sites in United States.
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 27 inclusion and 0 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: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 187 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of gynecological tumor specimens and serum from patients at GOG institutions (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2016.