ChemoFx® PRO – A Post-Market Data Collection Study

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Brief Title

ChemoFx® PRO - A Post-Market Data Collection Study

Official Title

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

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.
    

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


Primary Outcome

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.

Secondary Outcome

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

Condition

Ovarian Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2756

Start Date

October 2006

Completion Date

October 2012


Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00669422

Organization ID

PT-206 ChemoFx® PRO Study


Responsible Party

Sponsor

Study Sponsor

Precision Therapeutics


Study Sponsor

, , 


Verification Date

October 2012