ChemoFx® PRO - A Post-Market Data Collection Study
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Women's Studies, Endometrial Cancer |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | October 2006 |
Contact: | Lauren Stein |
Email: | registry@ptilabs.com |
Phone: | (412) 432-1350 |
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.
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.
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
We found this trial at
67
sites
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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533 Parnassus Ave
San Francisco, California 94122
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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University of South Alabama "University of South Alabama is a public institution that was founded...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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101 Dudley St
Providence, Rhode Island 02905
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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