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Fallopian Tube CancerNCT00238342

Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

A study testing proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry and biopsy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group at 107 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer. PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fallopian Tube Cancer, Ovarian Cancer
What is being tested?
proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry and biopsy
Type of treatment
Surgery or procedure
How many people
2,000 participants
Where
107 sitesUnited States
Study dates
Oct 2005to Oct 2007
Phase
Interventional
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Abnormal pelvic mass by physical examination or imaging test
  • Undiagnosed
  • Planning to undergo surgical evaluation within the next 3 weeks

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Surgery

  • See Disease Characteristics

Trial locations and contacts

107 sites in 1 country.

107 sites in 1 country

United States107 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Virginia Cancer Center at UV Health System

    Charlottesville, Virginia, 22908

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton Md, Maryland, 21921

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Florida Gynecologic Oncology - Fort Myers

    Fort Myers, Florida, 33901

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Metro Health Hospital

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Howard Community Hospital at Howard Regional Health System

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Women's Cancer Center - Las Vegas

    Las Vegas, Nevada, 89102

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Chicago Gynecologic Oncology

    Palatine, Illinois, 60067

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Williamette Gynecologic Oncology PC

    Portland, Oregon, 97213

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Washoe Cancer Services at Washoe Medical Center - Reno

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia, 24014

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Bayfront Medical Center

    St. Petersburg, Florida, 33701

  • Overlook Hospital

    Summit, New Jersey, 07902

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cancer Care Associates - Midtown Tulsa

    Tulsa, Oklahoma, 74104

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Aurora Women's Pavilion of West Allis Memorial Hospital

    West Allis, Wisconsin, 53227

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

Read the detailed description

OBJECTIVES:

Primary

  • Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.

Secondary

  • Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.

Tertiary

  • Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.
  • Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

  • Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.
  • Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Being tested
proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry, biopsy
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • proteomic profilingGenetic

  • surface-enhanced laser desorption/ionization-time of flight mass spectrometryOther

  • biopsyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionOct 2007 (estimated)

Resources

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
Diagnosis
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238342
Sponsor's protocol ID
CDR0000445437
Other IDs
GOG-0220
Status last verified
Apr 2007
First submitted
12 Oct 2005
Last updated
9 Feb 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry and biopsy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group at 107 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?

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: status not confirmed, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 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?

Results are not available in the source record.

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?

Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass). 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 NCT00238342.

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 9 Feb 2010.

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