ChemoFx® PRO - A Post-Market Data Collection Study

NCT00669422TerminatedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Precision Therapeutics

Enrollment

2756

Start Date

2006-10-01

Study Type

OBSERVATIONAL

Official Title

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal CancerUterine NeoplasmsEndometrial CancerVaginal CancerVulvar CancerCervical Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient pathology shows benign pathology for sample submitted
* Patient is not indicated to receive chemotherapy for their disease

Outcome Measures

Primary Outcomes

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.

Time frame: 24-36 Months depending on Disease Status

Secondary Outcomes

Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers.

Time frame: 24-36 Months depending on Disease Status

Locations

University of Alabama at Birmingham, Birmingham, United States

University of South Alabama, Mobile, United States

University of California San Francisco, San Francisco, United States

Women's Cancer Center of Southern California, Sherman Oaks, United States

GOA Torrance Memorial, Torrance, United States

Hartford Hospital, Hartford, United States

Yale University, New Haven, United States

South Florida Center for Gynecologic Oncology, Boca Raton, United States

West Coast Gynecologic Oncology, Clearwater, United States

Florida Center for Gynecologic Oncology, Coconut Creek, United States

Comprehensive Gynecologic Oncology, Delray Beach, United States

Caruso and Gates MDs PA, Fort Lauderdale, United States

Florida Gynecologic Oncology, Fort Myers, United States

Gynecologic Oncology Associates, Hollywood, United States

Sarasota Memorial Hospital, Sarasota, United States

South Miami Gynecologic Oncology Group, South Miami, United States

Palm Beach Cancer Institute, West Palm Beach, United States

Southeastern Gynecologic Oncology, LLC, Riverdale, United States

Memorial Health University Medical Center, Savannah, United States

The Queens' Medical Center, Honolulu, United States

Rush University, Chicago, United States

NorthShore Medical Group, Evanston, United States

Indiana University, Indianapolis, United States

Women's Cancer Center, Covington, United States

CHRISTUS Schumpert Health System, Shreveport, United States

Sinai Hospital, Baltimore, United States

Women's Health Specialists, Silver Springs, United States

UMass Memorial Hospital, Worcester, United States

Karmanos Cancer Institute, Detroit, United States

Henry Ford Health System, Detroit, United States

Gynecologic Oncology of West Michigan, Grand Rapids, United States

Mississippi Oncology Associates, Jackson, United States

Atlantic Health Systems, Morristown, United States

Jersey Shore University Medical Center, Neptune City, United States

Gara M Sommers MD, Teaneck, United States

Cooper Health System, Voorhees Township, United States

Women's Cancer Care Associates, Albany, United States

St. John's Episcopal Hospital, Atlantic Beach, United States

Roswell Park Cancer Institute, Buffalo, United States

North Shore LIJ Health System, Manhassett, United States

Columbia University Medical Center, New York, United States

New York Downtown Hospital, New York, United States

Montefiore Medical Center, The Bronx, United States

Hope: A Women's Cancer Center, Asheville, United States

Blumenthal Cancer Center, Charlotte, United States

Presbyterian Gynecologic Oncology, Charlotte, United States

Duke University Medical Center, Durham, United States

North Hanover Regional Medical Center, Wilmington, United States

University of Cincinnati, Cincinnati, United States

OSU Gynecologic Oncology, Columbus, United States

Oklahoma Gynecologic Oncology Group, Oklahoma City, United States

Oregon Health & Science University, Portland, United States

Allegheny-Singer Research Institute, Pittsburgh, United States

The Western Pennsylvania Hospital, Pittsburgh, United States

Women & Infants Hospital of Rhode Island, Providence, United States

Medical University of South Carolina Hospital, Charleston, United States

Sandford USD Health System, Sioux Falls, United States

Chattanooga Gynecologic Oncology, Chattanooga, United States

Chattanooga's Program in Women's Oncology, Chattanooga, United States

Thomas W. McDonald MD, Knoxville, United States

North Texas Gynecologic Oncology, Dallas, United States

Brooke Army Medical Center, Fort Sam Houston, United States

South Texas Gynecologic Oncology, San Antonio, United States

North Virigina Pelvic Surgery Associates, Annandale, United States

Carilion Clinic Gynecologic Oncology, Roanoke, United States

Mohammed Ashraf MD, Morgantown, United States

Aurora West Allis Medical Center, West Allis, United States

ChemoFx® PRO - A Post-Market Data Collection Study