IRB Study Number PROTID17013
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
Primary Objectives
• 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 Objectives
• 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
Inclusion Criteria
• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing as standard of care (male or female)
• Informed consent form signed on the same day or before enrollment
• New primary lesion
• Patients 18 years of age or older
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria, or insufficient material to obtain full genome data
• Metastatic disease
• Recurrent disease
• Stage 0 disease
