Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass
- Conditions
- Ovarian CancerFallopian Tube Cancer
- Registration Number
- NCT00238342
- Lead Sponsor
- Gynecologic Oncology Group
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (107)
Bayfront Medical Center
🇺🇸St. Petersburg, Florida, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
🇺🇸Voorhees, New Jersey, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Women's Cancer Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Highlands Oncology Group - Fayetteville
🇺🇸Fayetteville, Arkansas, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Florida Gynecologic Oncology - Fort Myers
🇺🇸Fort Myers, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Chicago Gynecologic Oncology
🇺🇸Palatine, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Howard Community Hospital at Howard Regional Health System
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton Md, Maryland, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Washoe Cancer Services at Washoe Medical Center - Reno
🇺🇸Reno, Nevada, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Good Samaritan Hospital Medical Center
🇺🇸West Islip, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Virginia Cancer Center at UV Health System
🇺🇸Charlottesville, Virginia, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Carilion Gynecologic Oncology Associates
🇺🇸Roanoke, Virginia, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
St. Joseph Medical Center at Franciscan Health System
🇺🇸Tacoma, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Aurora Women's Pavilion of West Allis Memorial Hospital
🇺🇸West Allis, Wisconsin, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Saint Mary's Regional Medical Center
🇺🇸Reno, Nevada, United States
Gynecologic Oncology Network
🇺🇸Greenville, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Williamette Gynecologic Oncology PC
🇺🇸Portland, Oregon, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States