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Molecular Testing Rapid Cycle Research

PCORI is interested in leraning about the patterns of use of molecular biomarkers (tumor or germline) and associated targeted cancer therapies for patients with new-onset solid tumors (all single primary invasive solid tumors) cared for in a variety of community and academic care settings. PCORI is also interested in knowing the frequency of use of targeted therapy agents for each cancer, the frequency of testing prior to use of these agents, the concordance between testing results and choices of therapies, and the frequency with which these therapies are used for approved indications vs. "off-label." The request is also intended to test and expand the capacity of PCORnet to describe the details of cancer pathology, results of testing, cancer treatment and outcomes. It is intended to inform key stakeholder groups, particularly payers, on current patterns of care and to assess capacity for future comparative outcomes studies, both observational and randomized. Molecular genetics laboratories employ a variety of methods to detect a variety of therapeutically relevant genetic alterations. The main types are those that analyze DNA, those that analyze mRNA expression, and those that analyze protein expression. 

Specific Analytic Aims are:

  1. (Use Characteristics). In a cohort of patients with an invasive single primary solid tumor, describe the use of common molecular tumor and, in some cases, germline biomarker testing and associated targeted cancer therapies. 
  2. (Test Results). In a subcohort of patients identify those who had molecular biomarker testing and for whom a test result was available, and determine whether the selected treatment was in accordance with the test result.
  3. (Completeness and Outcomes). Using the cohort from Aim 1 in sites with linked claims data, assess the completeness of the EHR-derived data for identifying cancer treatments, molecular tests and outcomes.
  4. (Network Capacity). Using the results from Aims 1-3, from the DRN OC descriptive results, and surveys of network partner data, synthesize and report lessons learned about network capacity for conducting pragmatic outcomes research in cancer including how well networks are able to capture the diagnoses, therapies, tests, test results, and outcomes of treatment and what issues must be overcome.

 

Other Information:

  • Principal Investigator: Betsy Chrischilles, PhD; University of Iowa
  • Participating GPC Sites: 
    • University of Iowa
    • University of Kansas Medical Center
    • University of Nebraska Medical Center
    • University of Minnesota
    • Marshfield Clinic Research Institute
    • University of Texas Southwestern
  • Project Budget: $1,078,093
  • Project Period: September 1, 2017 - May 31, 2018

 


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