Study of Molecular Profile-Related Evidence to Determine Individualized Therapy for Advanced or Poor Prognosis Cancers
- Conditions
- Cancer
- Registration Number
- NCT02534675
- Lead Sponsor
- University of California, San Diego
- Brief Summary
The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information from the patient's medical record regarding the tests and treatments they have received, or will receive, for their cancer will be collected. Genomic testing on tissue from the primary tumor or metastases will be used to match therapy recommendations. Patients in which there is no appropriate matched therapy will receive systemic chemotherapy according to their treating physician's discretion. This information will be used to describe whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.
- Detailed Description
This is a prospective, open label navigational investigation to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with incurable malignancies. This is a non-randomized, histology-agnostic trial. While it is known that individual histologies are composed of a heterogeneous mix of genomic alterations, it is not clear that one case mix is better or worse than another. Thus, a strategy of molecular matching that may apply across cancers is being tested. All eligible and consented patients will have their tumor tissues genomic profiled by Foundation Medicine's FoundationOne genomic analysis. Patients will be stratified into Group 1 (treatment naïve, unresectable/medically unfit for surgery), Group 2 (treatment naïve, metastatic), and Group 3 (prior treated), respectively. Following analysis for genomic alterations, matched therapy, if available, will be recommended by the Study Committee or Molecular Tumor Board. If the patients received the matched therapy, they are designated as in Arm A. Otherwise, if the patients received the unmatched therapy (i.e., treating physician's choice of traditional systemic chemotherapy), they are designated as in Arm B. The study feasibility will be measured by the ability to enroll patients, the acceptable turnaround time and the actionable information obtained from the genomic profiling, and the viability of identifying and delivering the matched therapy. The treatment efficacy will be determined among the patients groups and treatment arms. The safety profile of the treatment will also be assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who receive the molecularly targeted matched treatment after recommendations based on genomic analysis 3 years Number of patients who received study therapy after recommendations after genetic test versus patients who did not
- Secondary Outcome Measures
Name Time Method Time from informed consent to receipt of genomic analysis 3 years To calculate the time between getting the patient's consent and them receiving their genetic test
Proportion of patients with actionable genomic alteration 3 years To calculate the number of patients who have a genetic test result that can be matched with appropriate treatment that can target their specific mutation
Proportion of patients who consent to enroll into the study 3 years To calculate the number of patients who have consented to be on the study
Proportion of patients with insurance coverage for receiving molecularly targeted matched treatment based on genomic analysis 3 years To calculate the number of patients who are covered by insurance to receive treatment appropriately targeting their specific genetic test result
Trial Locations
- Locations (2)
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States