From the blog

ChemoFx® PRO – A Post-Market Data Collection Study

Published: April 25, 2008

Primary Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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.

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 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


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
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