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Clinical Trials in the USA / NCT03053193
Recruiting Observational

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

NCT03053193 · tracked via the Priya Life Science USA tracker
Sponsor
Agendia
Phase
Observational
Started
2017-04-28
Last updated
2025-08-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

MammaPrint, BluePrint, and Full-Genome Testing

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (134)

FacilityCityRegionStatus
CHS Grandview Birmingham Alabama Completed
Providence Alaska Medical Center Anchorage Alaska Recruiting
Arizona Oncology Associates, PC Phoenix Arizona Recruiting
Arizona Oncology Associates, PC - HOPE Tucson Arizona Recruiting
Adventist Health - Bakersfield Bakersfield California Recruiting
Comprehensive Cancer Center at Desert Regional Medical Center Palm Springs California Recruiting
North Valley Breast Clinic Redding California Recruiting
UCSF Breast Care Center San Francisco California Recruiting
Valley Breast Care Van Nuys California Recruiting
Rocky Mountain Cancer Centers Aurora Colorado Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Comprehensive Breast Care of Denver Denver Colorado Recruiting
Rocky Mountain Cancer Center - Lakewood Lakewood Colorado Recruiting
Vail Health - Shaw Cancer Center Vail Colorado Recruiting
St. Mary's Hospital Waterbury Connecticut Recruiting
Medical Oncology and Hematology Consultants Newark Delaware Recruiting
Breast Specialists of South Florida Atlantis Florida Recruiting
JFK Medical Center Atlantis Florida Recruiting
Boca Raton Regional Hospital Boca Raton Florida Recruiting
Morton Plant Hospital Clearwater Florida Recruiting
Halifax Health - Center for Oncology Daytona Beach Florida Recruiting
Baptist MD Anderson Cancer Center Jacksonville Florida Recruiting
University of Florida - Jacksonville Jacksonville Florida Completed
St. Vincent Hospital / Mayo Clinic Jacksonville Florida Active Not Recruiting
Lakeland Regional Cancer Center Lakeland Florida Recruiting
Sylvester Comprehensive Cancer Center - University of Miami Miami Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc Miami Florida Recruiting
Cancer Care Centers of Brevard Rockledge Florida Recruiting
St. Joseph's Hospital - Baycare Tampa Florida Recruiting
University of South Florida Tampa Florida Recruiting
Winter Haven Hospital Winter Haven Florida Recruiting
Phoebe Health Albany Georgia Recruiting
Piedmont Cancer Institute Atlanta Georgia Recruiting
Emory University - Winship Cancer Institute Atlanta Georgia Recruiting
Southeast Georgia Health System - Physician Associates Brunswick Georgia Recruiting
DeKalb Medical Center Decatur Georgia Completed
Candler Hospital Savannah Georgia Recruiting
Tift Regional Health System Tifton Georgia Recruiting
University of Illinois at Chicago Chicago Illinois Recruiting
Alexian Brothers Medical Center Elk Grove Village Illinois Recruiting

+ 94 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03053193 on ClinicalTrials.gov ↗ ← All trials in the USA