ChemoFx® PRO - A Post-Market Data Collection Study
October 4, 2012 updated by: Precision Therapeutics
ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes
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.
Study Overview
Status
Terminated
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.
Study Type
Observational
Enrollment (Actual)
2756
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
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Mobile, Alabama, United States, 36688
- University of South Alabama
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California
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San Francisco, California, United States, 94115
- University of California San Francisco
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Sherman Oaks, California, United States, 91403
- Women's Cancer Center of Southern California
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Torrance, California, United States, 91403
- GOA Torrance Memorial
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Connecticut
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Hartford, Connecticut, United States, 06106
- Hartford Hospital
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New Haven, Connecticut, United States, 06111
- Yale University
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Florida
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Boca Raton, Florida, United States, 33487
- South Florida Center for Gynecologic Oncology
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Clearwater, Florida, United States, 33756
- West Coast Gynecologic Oncology
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Coconut Creek, Florida, United States, 33073
- Florida Center for Gynecologic Oncology
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Delray Beach, Florida, United States, 33444
- Comprehensive Gynecologic Oncology
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Fort Lauderdale, Florida, United States, 33308
- Caruso and Gates MDs PA
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Fort Myers, Florida, United States, 33901
- Florida Gynecologic Oncology
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Hollywood, Florida, United States, 33021
- Gynecologic Oncology Associates
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
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South Miami, Florida, United States, 33143
- South Miami Gynecologic Oncology Group
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West Palm Beach, Florida, United States, 33401
- Palm Beach Cancer Institute
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Georgia
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Riverdale, Georgia, United States, 30274
- Southeastern Gynecologic Oncology, LLC
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- The Queens' Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University
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Evanston, Illinois, United States, 60201
- Northshore Medical Group
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Louisiana
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Covington, Louisiana, United States, 70433
- Women's Cancer Center
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Shreveport, Louisiana, United States, 71101
- CHRISTUS Schumpert Health System
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Maryland
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Baltimore, Maryland, United States, 21215
- Sinai Hospital
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Silver Springs, Maryland, United States, 20852
- Women's Health Specialists
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Massachusetts
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Worcester, Massachusetts, United States, 01605
- UMass Memorial Hospital
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Grand Rapids, Michigan, United States, 49546
- Gynecologic Oncology of West Michigan
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Mississippi
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Jackson, Mississippi, United States, 39216
- Mississippi Oncology Associates
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New Jersey
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Morristown, New Jersey, United States, 07962
- Atlantic Health Systems
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Neptune, New Jersey, United States, 07765
- Jersey Shore University Medical Center
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Teaneck, New Jersey, United States, 07066
- Gara M Sommers MD
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Voorhees, New Jersey, United States, 08043
- Cooper Health System
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New York
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Albany, New York, United States, 12208
- Women's Cancer Care Associates
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Atlantic Beach, New York, United States, 11509
- St. John's Episcopal Hospital
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Bronx, New York, United States, 10461
- Montefiore Medical Center
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Manhassett, New York, United States, 11030
- North Shore Lij Health System
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New York, New York, United States, 10032
- Columbia University Medical center
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New York, New York, United States, 10038
- New York Downtown Hospital
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North Carolina
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Asheville, North Carolina, United States, 28806
- Hope: A Women's Cancer Center
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Charlotte, North Carolina, United States, 28204
- Blumenthal Cancer Center
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Charlotte, North Carolina, United States, 28233
- Presbyterian Gynecologic Oncology
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Wilmington, North Carolina, United States, 28402
- North Hanover Regional Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati
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Columbus, Ohio, United States, 43026
- OSU Gynecologic Oncology
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Oklahoma Gynecologic Oncology Group
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- The Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, United States, 15224
- Allegheny-Singer Research Institute
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Women & Infants Hospital of Rhode Island
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South Carolina
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Charleston, South Carolina, United States, 29403
- Medical University of South Carolina Hospital
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sandford USD Health System
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Chattanooga's Program In Women's Oncology
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Chattanooga, Tennessee, United States, 37403
- Chattanooga Gynecologic Oncology
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Knoxville, Tennessee, United States, 37922
- Thomas W. McDonald MD
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Texas
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Dallas, Texas, United States, 75251
- North Texas Gynecologic Oncology
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Ft. Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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San Antonio, Texas, United States, 78258
- South Texas Gynecologic Oncology
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Virginia
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Annandale, Virginia, United States, 22003
- North Virigina Pelvic Surgery Associates
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Roanoke, Virginia, United States, 24016
- Carilion Clinic Gynecologic Oncology
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West Virginia
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Morgantown, West Virginia, United States, 26505
- Mohammed Ashraf MD
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Wisconsin
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West Allis, Wisconsin, United States, 53227
- Aurora West Allis Medical Center
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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
Sampling Method
Non-Probability Sample
Study Population
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
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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24-36 Months depending on Disease Status
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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24-36 Months depending on Disease Status
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Ness 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.
- O'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.
- McLeod 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.
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, 2006
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
April 25, 2008
First Submitted That Met QC Criteria
April 28, 2008
First Posted (Estimate)
April 30, 2008
Study Record Updates
Last Update Posted (Estimate)
October 5, 2012
Last Update Submitted That Met QC Criteria
October 4, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Vaginal Diseases
- Vulvar Diseases
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Endometrial Neoplasms
- Vulvar Neoplasms
- Vaginal Neoplasms
- Uterine Neoplasms
Other Study ID Numbers
- PT-206 ChemoFx® PRO Study
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.