ChemoFx® PRO - A Post-Market Data Collection Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Uterine Neoplasms, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Cervical Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Uterine Neoplasms, Vulvar Cancer, Endometrial Cancer, Cervical Cancer, Assay, Chemotherapy, Recurrent, Refractory, Persistent, Chemoresponse, Sensitivity, Precision Therapeutics, ChemoFx