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Back|NCT03053193Recruiting
Official Title

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Sponsor
Agendia
Enrollment
30,000
Timeline
Apr 2017 → Dec 2037
About This Study

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 Criteria

Inclusion Criteria

  • 1Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
  • 2Informed consent form signed on the same day or before enrollment
  • 3New primary lesion

Exclusion Criteria

  • 1Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • 2Metastatic disease
  • 3Recurrent disease
  • 4Stage 0 disease

Locations

134 sites participating in this study

Emory University - Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Cathy Graham, MD

CHS Grandview

Birmingham, Alabama 35243

Completed

Providence Alaska Medical Center

Anchorage, Alaska 99508

Recruiting

Theodore Kim

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →