MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
Recruiting · NCT03053193 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MammaPrint, BluePrint, and Full-Genome Testing
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
60 locations listed across 29 US states.
- CHS Grandview - Birmingham, Alabama, United States
- Providence Alaska Medical Center - Anchorage, Alaska, United States
- Arizona Oncology Associates, PC - Phoenix, Arizona, United States
- Arizona Oncology Associates, PC - HOPE - Tucson, Arizona, United States
- Adventist Health - Bakersfield - Bakersfield, California, United States
- Comprehensive Cancer Center at Desert Regional Medical Center - Palm Springs, California, United States
- North Valley Breast Clinic - Redding, California, United States
- UCSF Breast Care Center - San Francisco, California, United States
- Valley Breast Care - Van Nuys, California, United States
- Rocky Mountain Cancer Centers - Aurora, Colorado, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- Comprehensive Breast Care of Denver - Denver, Colorado, United States
- Rocky Mountain Cancer Center - Lakewood - Lakewood, Colorado, United States
- Vail Health - Shaw Cancer Center - Vail, Colorado, United States
- St. Mary's Hospital - Waterbury, Connecticut, United States
- Medical Oncology and Hematology Consultants - Newark, Delaware, United States
- Breast Specialists of South Florida - Atlantis, Florida, United States
- JFK Medical Center - Atlantis, Florida, United States
- Boca Raton Regional Hospital - Boca Raton, Florida, United States
- Morton Plant Hospital - Clearwater, Florida, United States
- Halifax Health - Center for Oncology - Daytona Beach, Florida, United States
- Baptist MD Anderson Cancer Center - Jacksonville, Florida, United States
- University of Florida - Jacksonville - Jacksonville, Florida, United States
- St. Vincent Hospital / Mayo Clinic - Jacksonville, Florida, United States
- Lakeland Regional Cancer Center - Lakeland, Florida, United States
- Sylvester Comprehensive Cancer Center - University of Miami - Miami, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc - Miami, Florida, United States
- Cancer Care Centers of Brevard - Rockledge, Florida, United States
- St. Joseph's Hospital - Baycare - Tampa, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Winter Haven Hospital - Winter Haven, Florida, United States
- Phoebe Health - Albany, Georgia, United States
- Piedmont Cancer Institute - Atlanta, Georgia, United States
- Emory University - Winship Cancer Institute - Atlanta, Georgia, United States
- Southeast Georgia Health System - Physician Associates - Brunswick, Georgia, United States
- DeKalb Medical Center - Decatur, Georgia, United States
- Candler Hospital - Savannah, Georgia, United States
- Tift Regional Health System - Tifton, Georgia, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- Alexian Brothers Medical Center - Elk Grove Village, Illinois, United States
- Saint Alexius Medical Center - Hoffman Estates, Illinois, United States
- Affiliated Oncologists - Oak Lawn, Illinois, United States
- Parkview Health - Fort Wayne, Indiana, United States
- Louisiana State University - Shreveport, Louisiana, United States
- Northern Light Breast Care - Portland, Maine, United States
- Luminis Health Center for Cancer & Blood Disorders - Annapolis, Maryland, United States
- Mercy Medical Center - Baltimore, Maryland, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Maryland Oncology Hematology - Bethesda - Bethesda, Maryland, United States
- Maryland Oncology Hematology - Brandywine - Brandywine, Maryland, United States
- Maryland Oncology Hematology - Clinton - Clinton, Maryland, United States
- Maryland Oncology Hematology, PA - Columbia, Maryland, United States
- UPMC at Western Maryland Health System - Cumberland, Maryland, United States
- Frederick Oncology Hematology Associates - Frederick, Maryland, United States
- Maryland Oncology Hematology - Aquilino Cancer Center - Rockville, Maryland, United States
- Maryland Oncology Hematology, PA - Silver Spring, Maryland, United States
- Mercy Medical Center - Springfield, Massachusetts, United States
- St. John Hospital - Grosse Pointe Woods, Michigan, United States
- Sparrow Cancer Center - Lansing, Michigan, United States
- Beaumont Breast Care Center - Royal Oak, Michigan, United States
Showing 60 of 134 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →