RESEARCH STUDIES & Clinical Trials

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

Phases

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Crozier, Jennifer

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

More Information

clinicaltrials.gov

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