ChemoFx® PRO - A Post-Market Data Collection Study
- Conditions
- Peritoneal CancerVaginal CancerVulvar CancerFallopian Tube CancerCervical CancerOvarian CancerEndometrial CancerUterine Neoplasms
- Registration Number
- NCT00669422
- Lead Sponsor
- Precision Therapeutics
- Brief Summary
This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.
- Detailed Description
The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.
ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.
In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.
The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2756
- Patient has been diagnosed with a solid tumor malignancy and their physician has received a final report for ChemoFx® after August 1, 2006
- Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
- Patient must be at least 18 years of age
- Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study. 24-36 Months depending on Disease Status
- Secondary Outcome Measures
Name Time Method Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers. 24-36 Months depending on Disease Status
Trial Locations
- Locations (67)
Sinai Hospital
🇺🇸Baltimore, Maryland, United States
OSU Gynecologic Oncology
🇺🇸Columbus, Ohio, United States
North Texas Gynecologic Oncology
🇺🇸Dallas, Texas, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
Rush University
🇺🇸Chicago, Illinois, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
North Virigina Pelvic Surgery Associates
🇺🇸Annandale, Virginia, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oklahoma Gynecologic Oncology Group
🇺🇸Oklahoma City, Oklahoma, United States
South Texas Gynecologic Oncology
🇺🇸San Antonio, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Hope: A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Thomas W. McDonald MD
🇺🇸Knoxville, Tennessee, United States
Gynecologic Oncology Associates
🇺🇸Hollywood, Florida, United States
UMass Memorial Hospital
🇺🇸Worcester, Massachusetts, United States
Mississippi Oncology Associates
🇺🇸Jackson, Mississippi, United States
Caruso and Gates MDs PA
🇺🇸Fort Lauderdale, Florida, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
CHRISTUS Schumpert Health System
🇺🇸Shreveport, Louisiana, United States
Cooper Health System
🇺🇸Voorhees, New Jersey, United States
Chattanooga's Program in Women's Oncology
🇺🇸Chattanooga, Tennessee, United States
Mohammed Ashraf MD
🇺🇸Morgantown, West Virginia, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Women's Cancer Center
🇺🇸Covington, Louisiana, United States
Women's Health Specialists
🇺🇸Silver Springs, Maryland, United States
West Coast Gynecologic Oncology
🇺🇸Clearwater, Florida, United States
GOA Torrance Memorial
🇺🇸Torrance, California, United States
NorthShore Medical Group
🇺🇸Evanston, Illinois, United States
New York Downtown Hospital
🇺🇸New York, New York, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Sandford USD Health System
🇺🇸Sioux Falls, South Dakota, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Florida Center for Gynecologic Oncology
🇺🇸Coconut Creek, Florida, United States
South Florida Center for Gynecologic Oncology
🇺🇸Boca Raton, Florida, United States
South Miami Gynecologic Oncology Group
🇺🇸South Miami, Florida, United States
Southeastern Gynecologic Oncology, LLC
🇺🇸Riverdale, Georgia, United States
Gara M Sommers MD
🇺🇸Teaneck, New Jersey, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Gynecologic Oncology of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Comprehensive Gynecologic Oncology
🇺🇸Delray Beach, Florida, United States
Women's Cancer Center of Southern California
🇺🇸Sherman Oaks, California, United States
North Shore LIJ Health System
🇺🇸Manhassett, New York, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Brooke Army Medical Center
🇺🇸Ft. Sam Houston, Texas, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
St. John's Episcopal Hospital
🇺🇸Atlantic Beach, New York, United States
Chattanooga Gynecologic Oncology
🇺🇸Chattanooga, Tennessee, United States
Atlantic Health Systems
🇺🇸Morristown, New Jersey, United States
Women's Cancer Care Associates
🇺🇸Albany, New York, United States
Presbyterian Gynecologic Oncology
🇺🇸Charlotte, North Carolina, United States
North Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
The Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Carilion Clinic Gynecologic Oncology
🇺🇸Roanoke, Virginia, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Medical University of South Carolina Hospital
🇺🇸Charleston, South Carolina, United States
The Queens' Medical Center
🇺🇸Honolulu, Hawaii, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States