MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MammaPrint, BluePrint, and Full-Genome Testing — DIAGNOSTIC_TEST
  Agendia will run MammaPrint and BluePrint tests using the full genome testing array.

Study Details

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.

Key Dates

Start date

Apr 28, 2017

Status verified

Aug 2025

Primary completion

Apr 30, 2037

Completion

Dec 31, 2037

Study Design

Enrollment

30,000 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [ Time Frame: 10 years ]

Central Contacts

• Michelle Landon, MS, CGC
  801-633-8215
  [email protected]

Locations (130)

Find similar trials in Birmingham, AL

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