MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Agendia
- Enrollment
- 30,000
- Locations
- 132
- Primary Endpoint
- A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
Study Overview
Brief Summary
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.
Detailed Description
The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.
Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.
Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.
Objectives:
- Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value
- Utilize shared registry infrastructure to examine smaller groups of interest
- Generate hypotheses for targeted subset analyses and trials based on full genome data
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
A shared registry infrastructure to examine smaller groups of interest.
Time Frame: 10 years
Create a shared registry infrastructure to examine smaller groups of interest.
Secondary Outcomes
- Subset analyses based on full genome data will be created.(10 years)