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MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Primary:

Create a large scale, population-based registry of full genome expression data matched with clinical data to investigate new gene associations with prognostic and/or predictive value
Utilize registry data to graduate identified expression signatures into subset trials and recommend interventional trials

Secondary:
Generate hypotheses for targeted subset trials based on full genome data
Measure the impact of MammaPrint and BluePrint on physician decisions and confidence
Measure impact of assays on patient decisions and confidence
Demonstrate prognostic and predictive efficacy in groups beyond those currently clinically indicated for MammaPrint and BluePrint
Track changes in genomic signature through serial MammaPrint and BluePrint signatures in the neoadjuvant setting
Determine prognostic and predictive power of MammaPrint, and BluePrint as measured by outcomes
Validate MammaPrint, and BluePrint reclassification of traditional clinicopathological subtypes
Capture clinical outcomes in specific race and ethnicity groups to broaden relative genomic signature data

Protocol Number: 042409
Phase: N/A
Applicable Disease Sites: Breast
Principal Investigator: Susan Pories
Scope: National
Participating Institutions:
  • Rutgers University

For further information about clinical trials, please contact us at 732-235-7356.