ChemoFx® PRO - A Post-Market Data Collection Study
1 other identifier
observational
2,756
1 country
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2006
Longer than P75 for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 30, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 5, 2012
October 1, 2012
April 25, 2008
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Eligibility Criteria
Approximately 3,000 patients from 150 academic and community based physicians in the United States. Patients have a confirmed solid tumor malignancy and their tissue specimen has been submitted to Precision Therapeutics, Inc. as part of the patient's medical care
You may qualify if:
- 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.
You may not qualify if:
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of South Alabama
Mobile, Alabama, 36688, United States
University of California San Francisco
San Francisco, California, 94115, United States
Women's Cancer Center of Southern California
Sherman Oaks, California, 91403, United States
GOA Torrance Memorial
Torrance, California, 91403, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06111, United States
South Florida Center for Gynecologic Oncology
Boca Raton, Florida, 33487, United States
West Coast Gynecologic Oncology
Clearwater, Florida, 33756, United States
Florida Center for Gynecologic Oncology
Coconut Creek, Florida, 33073, United States
Comprehensive Gynecologic Oncology
Delray Beach, Florida, 33444, United States
Caruso and Gates MDs PA
Fort Lauderdale, Florida, 33308, United States
Florida Gynecologic Oncology
Fort Myers, Florida, 33901, United States
Gynecologic Oncology Associates
Hollywood, Florida, 33021, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
South Miami Gynecologic Oncology Group
South Miami, Florida, 33143, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Southeastern Gynecologic Oncology, LLC
Riverdale, Georgia, 30274, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
The Queens' Medical Center
Honolulu, Hawaii, 96813, United States
Rush University
Chicago, Illinois, 60612, United States
NorthShore Medical Group
Evanston, Illinois, 60201, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Women's Cancer Center
Covington, Louisiana, 70433, United States
CHRISTUS Schumpert Health System
Shreveport, Louisiana, 71101, United States
Sinai Hospital
Baltimore, Maryland, 21215, United States
Women's Health Specialists
Silver Springs, Maryland, 20852, United States
UMass Memorial Hospital
Worcester, Massachusetts, 01605, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan, 49546, United States
Mississippi Oncology Associates
Jackson, Mississippi, 39216, United States
Atlantic Health Systems
Morristown, New Jersey, 07962, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07765, United States
Gara M Sommers MD
Teaneck, New Jersey, 07066, United States
Cooper Health System
Voorhees Township, New Jersey, 08043, United States
Women's Cancer Care Associates
Albany, New York, 12208, United States
St. John's Episcopal Hospital
Atlantic Beach, New York, 11509, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
North Shore LIJ Health System
Manhassett, New York, 11030, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York Downtown Hospital
New York, New York, 10038, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Hope: A Women's Cancer Center
Asheville, North Carolina, 28806, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Presbyterian Gynecologic Oncology
Charlotte, North Carolina, 28233, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
North Hanover Regional Medical Center
Wilmington, North Carolina, 28402, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
OSU Gynecologic Oncology
Columbus, Ohio, 43026, United States
Oklahoma Gynecologic Oncology Group
Oklahoma City, Oklahoma, 73112, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15224, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, 29403, United States
Sandford USD Health System
Sioux Falls, South Dakota, 57105, United States
Chattanooga Gynecologic Oncology
Chattanooga, Tennessee, 37403, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
Thomas W. McDonald MD
Knoxville, Tennessee, 37922, United States
North Texas Gynecologic Oncology
Dallas, Texas, 75251, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
South Texas Gynecologic Oncology
San Antonio, Texas, 78258, United States
North Virigina Pelvic Surgery Associates
Annandale, Virginia, 22003, United States
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, 24016, United States
Mohammed Ashraf MD
Morgantown, West Virginia, 26505, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Related Publications (4)
Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
PMID: 14974761BACKGROUNDNess RB, Wisniewski SR, Eng H, Christopherson W. Cell viability assay for drug testing in ovarian cancer: in vitro kill versus clinical response. Anticancer Res. 2002 Mar-Apr;22(2B):1145-9.
PMID: 12168915BACKGROUNDO'Meara AT, Sevin BU. Predictive value of the ATP chemosensitivity assay in epithelial ovarian cancer. Gynecol Oncol. 2001 Nov;83(2):334-42. doi: 10.1006/gyno.2001.6395.
PMID: 11606094BACKGROUNDMcLeod HL, King CR, Marsh S. Application of pharmacogenomics in the individualization of chemotherapy for gastrointestinal malignancies. Clin Colorectal Cancer. 2004 Jun;4 Suppl 1:S43-7. doi: 10.3816/ccc.2004.s.007.
PMID: 15212705BACKGROUND
Biospecimen
Leftover tumor cells from the test and pathology slides will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 30, 2008
Study Start
October 1, 2006
Study Completion
October 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10