MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
Recruiting now
Conditions studied: Breast Cancer
In brief
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 facts
- Study ID
- NCT03053193
- Run by
- Agendia
- People needed
- 30000
- Starts
- 2017-04-28
- Expected to finish
- 2037-12-01
- Last updated by the study team
- 2025-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease
Where it is running
- Sylvester Comprehensive Cancer Center - University of Miami — Miami, Florida, United States (enrolling)
- Miami Cancer Institute at Baptist Health, Inc — Miami, Florida, United States (enrolling)
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States (enrolling)
- Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
- Arizona Oncology Associates, PC — Phoenix, Arizona, United States (enrolling)
- North Valley Breast Clinic — Redding, California, United States (enrolling)
- UCSF Breast Care Center — San Francisco, California, United States (enrolling)
- Valley Breast Care — Van Nuys, California, United States (enrolling)
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
- Adventist Health - Bakersfield — Bakersfield, California, United States (enrolling)
- Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs, California, United States (enrolling)
- Rocky Mountain Cancer Center - Lakewood — Lakewood, Colorado, United States (enrolling)
- Vail Health - Shaw Cancer Center — Vail, Colorado, United States (enrolling)
- St. Mary's Hospital — Waterbury, Connecticut, United States (enrolling)
- Medical Oncology and Hematology Consultants — Newark, Delaware, United States (enrolling)
- Breast Specialists of South Florida — Atlantis, Florida, United States (enrolling)
- JFK Medical Center — Atlantis, Florida, United States (enrolling)
- Boca Raton Regional Hospital — Boca Raton, Florida, United States (enrolling)
- Morton Plant Hospital — Clearwater, Florida, United States (enrolling)
- Halifax Health - Center for Oncology — Daytona Beach, Florida, United States (enrolling)
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
- University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
- Comprehensive Breast Care of Denver — Denver, Colorado, United States (enrolling)
- Lakeland Regional Cancer Center — Lakeland, Florida, United States (enrolling)
- Cancer Care Centers of Brevard — Rockledge, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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