MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Agendia
30,000 participants
Apr 28, 2017
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria4
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease
Interventions
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
Locations(134)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03053193