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

February 6, 2010 updated by: Gynecologic Oncology Group

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Washington Regional Medical Center
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group - Fayetteville
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Los Angeles, California, United States, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Gynecologic Oncology - Fort Myers
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
      • St. Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Palatine, Illinois, United States, 60067
        • Chicago Gynecologic Oncology
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Elkton Md, Maryland, United States, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Metro Health Hospital
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute - Saginaw
      • St. Joseph, Michigan, United States, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-6805
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Women's Cancer Center - Las Vegas
      • Reno, Nevada, United States, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, United States, 89502
        • Washoe Cancer Services at Washoe Medical Center - Reno
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Morristown, New Jersey, United States, 07962
        • Carol G. Simon Cancer Center at Morristown Memorial Hospital
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
      • Voorhees, New Jersey, United States, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • West Islip, New York, United States, 11795
        • Good Samaritan Hospital Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, United States, 27835-6028
        • Leo W. Jenkins Cancer Center at ECU Medical School
      • Greenville, North Carolina, United States, 27834
        • Gynecologic Oncology Network
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Canton, Ohio, United States, 44710-1799
        • Aultman Hospital Cancer Center at Aultman Health Foundation
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Mentor, Ohio, United States, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Oregon
      • Portland, Oregon, United States, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97213
        • Williamette Gynecologic Oncology PC
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Texas
      • Galveston, Texas, United States, 77555-0361
        • University of Texas Medical Branch
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center at UV Health System
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Carilion Gynecologic Oncology Associates
    • Washington
      • Auburn, Washington, United States, 98002
        • Auburn Regional Center for Cancer Care
      • Centralia, Washington, United States, 98531-9027
        • Providence Centralia Hospital
      • Federal Way, Washington, United States, 98003
        • St. Francis Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Puyallup, Washington, United States, 98372
        • Good Samaritan Cancer Center
      • Tacoma, Washington, United States, 98405
        • Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, United States, 98499
        • St. Clare Hospital
      • Tacoma, Washington, United States, 98405-3004
        • St. Joseph Medical Center at Franciscan Health System
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • West Allis, Wisconsin, United States, 53227
        • Aurora Women's Pavilion of West Allis Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Elise C. Kohn, MD, NCI - Medical Oncology Branch
  • Samir N. Khleif, MD, National Cancer Institute (NCI)
  • Larry J. Copeland, MD, Ohio State University Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ANTICIPATED)

October 1, 2007

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (ESTIMATE)

October 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2010

Last Update Submitted That Met QC Criteria

February 6, 2010

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000445437
  • GOG-0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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