Clinical Trial ID: NCT03053193
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
Status
Open
Description
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
Objective
1. 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 2. Utilize registry data to graduate identified expression signatures into subset trials and recommend interventional trials
Treatment
MammaPrint and BluePrint Testing All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.
Conditions
Other
Age Group
Adult
Main Investiagtor
Samiian, Laila
Practice
Breast
Scope
National
Participating Institutions
Baptist MD Anderson Cancer Center
Eligibility
Inclusion Criteria: Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) Informed consent form signed on the same day or before enrollment New primary lesion Exclusion Criteria: Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria Metastatic disease Recurrent disease Stage 0 disease
Nct ID Number
NCT03053193
Secondary Trial ID Number
Flex Registry
Keywords
Observational