MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
- Registration Number
- NCT03053193
- Lead Sponsor
- Agendia
- Brief 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.
- Detailed Description
The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.
Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.
Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.
Objectives:
* Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value
* Utilize shared registry infrastructure to examine smaller groups of interest
* Generate hypotheses for targeted subset analyses and trials based on full genome data
FLEX is an observational (phase IV) study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30000
- 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
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MammaPrint and BluePrint testing MammaPrint, BluePrint, and Full-Genome Testing All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.
- Primary Outcome Measures
Name Time Method A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. 10 years Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
A shared registry infrastructure to examine smaller groups of interest. 10 years Create a shared registry infrastructure to examine smaller groups of interest.
- Secondary Outcome Measures
Name Time Method Subset analyses based on full genome data will be created. 10 years Use full genome data to analyze subsets.
Trial Locations
- Locations (132)
Piedmont Cancer Institute
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Texas Oncology - Memorial City
🇺🇸Houston, Texas, United States
TriHealth Cancer Institutes
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Minnesota Oncology
🇺🇸Minneapolis, Minnesota, United States
Texas Oncology, PA - Metropolitan
🇺🇸San Antonio, Texas, United States
Texas Oncology, PA - Northeast
🇺🇸San Antonio, Texas, United States
UT Health Cancer Center
🇺🇸San Antonio, Texas, United States
Texas Oncology PA -San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Texas Oncology, PA - Stone Oak
🇺🇸San Antonio, Texas, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Miami Cancer Institute at Baptist Health, Inc
🇺🇸Miami, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Adventist Health - Bakersfield
🇺🇸Bakersfield, California, United States
St. Vincent Hospital / Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Breast Specialists of South Florida
🇺🇸Atlantis, Florida, United States
Halifax Health - Center for Oncology
🇺🇸Daytona Beach, Florida, United States
Providence - Providence Park Hospital
🇺🇸Southfield, Michigan, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Medical Oncology and Hematology Consultants
🇺🇸Newark, Delaware, United States
Emory University - Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Boone Hospital Center
🇺🇸Columbia, Missouri, United States
North Valley Breast Clinic
🇺🇸Redding, California, United States
Valley Breast Care
🇺🇸Van Nuys, California, United States
Rocky Mountain Cancer Center - Lakewood
🇺🇸Lakewood, Colorado, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Maryland Oncology Hematology - Brandywine
🇺🇸Brandywine, Maryland, United States
Sylvester Comprehensive Cancer Center - University of Miami
🇺🇸Miami, Florida, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Candler Hospital
🇺🇸Savannah, Georgia, United States
Comprehensive Cancer Center at Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Vail Health - Shaw Cancer Center
🇺🇸Vail, Colorado, United States
Cancer Care Centers of Brevard
🇺🇸Rockledge, Florida, United States
Affiliated Oncologists
🇺🇸Oak Lawn, Illinois, United States
CHRISTUS Spohn Cancer Center
🇺🇸Corpus Christi, Texas, United States
Texas Oncology - Presbyterian
🇺🇸Dallas, Texas, United States
University of Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Rochester - Pluta Cancer Center
🇺🇸Rochester, New York, United States
Winter Haven Hospital
🇺🇸Winter Haven, Florida, United States
Tift Regional Health System
🇺🇸Tifton, Georgia, United States
UPMC at Western Maryland Health System
🇺🇸Cumberland, Maryland, United States
Northern Light Breast Care
🇺🇸Portland, Maine, United States
Southeast Georgia Health System - Physician Associates
🇺🇸Brunswick, Georgia, United States
Louisiana State University
🇺🇸Shreveport, Louisiana, United States
Saint Alexius Medical Center
🇺🇸Hoffman Estates, Illinois, United States
Northwell Health- Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Sparrow Cancer Center
🇺🇸Lansing, Michigan, United States
Hematology Oncology Center of Rockland at Nyack
🇺🇸Nyack, New York, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Texas Oncology - Carrollton
🇺🇸Carrollton, Texas, United States
Kings County Hospital
🇺🇸New York, New York, United States
Comprehensive Breast Care
🇺🇸Troy, Michigan, United States
DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Methodist Dallas Cancer Center
🇺🇸Dallas, Texas, United States
University of Pittsburgh Medical Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
St. John Hospital
🇺🇸Grosse Pointe Woods, Michigan, United States
Alliance Cancer Specialists
🇺🇸Horsham, Pennsylvania, United States
Grandview Hospital
🇺🇸Sellersville, Pennsylvania, United States
Texas Oncology - Grapevine
🇺🇸Grapevine, Texas, United States
Texas Oncology - Sugar Land
🇺🇸Sugar Land, Texas, United States
NYU Winthrop Hospital
🇺🇸Mineola, New York, United States
Northwell Health- Phelps Hospital
🇺🇸Tarrytown, New York, United States
Tidelands Health Coastal Carolina Breast Center
🇺🇸Georgetown, South Carolina, United States
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Texas Oncology - Allen
🇺🇸Allen, Texas, United States
Texas Oncology - Denton
🇺🇸Denton, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Oncology Consultants
🇺🇸Katy, Texas, United States
Texas Oncology - Longview
🇺🇸Longview, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Texas Oncology Willowbrook
🇺🇸Houston, Texas, United States
Texas Oncology - Plano East
🇺🇸Plano, Texas, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Texas Tech UHSC - Southwest Cancer Center
🇺🇸Lubbock, Texas, United States
Texas Oncology - Plano West
🇺🇸Plano, Texas, United States
Texas Oncology - Waco
🇺🇸Waco, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
University General Hospital Alexandra
🇬🇷Athens, Greece
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Ogden Regional Cancer Center
🇺🇸Ogden, Utah, United States
Skagit Valley Hospital
🇺🇸Mount Vernon, Washington, United States
CHS Grandview
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Associates, PC
🇺🇸Phoenix, Arizona, United States
UCSF Breast Care Center
🇺🇸San Francisco, California, United States
Comprehensive Breast Care of Denver
🇺🇸Denver, Colorado, United States
Legacy Good Samaritan Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Nashville Breast Center
🇺🇸Nashville, Tennessee, United States
Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
William Osler Cancer Centre
🇨🇦Brampton, Ontario, Canada
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
St. Joseph's Hospital - Baycare
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Maryland Oncology Hematology - Bethesda
🇺🇸Bethesda, Maryland, United States
Phoebe Health
🇺🇸Albany, Georgia, United States
Broome Oncology
🇺🇸Binghamton, New York, United States
Consultants in Medical Oncology and Hematology, P.C.
🇺🇸Broomall, Pennsylvania, United States
St. Mary's Hospital
🇺🇸Waterbury, Connecticut, United States
Beaumont Breast Care Center
🇺🇸Royal Oak, Michigan, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Parkview Health
🇺🇸Fort Wayne, Indiana, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Roper St. Francis Physician Partners - Breast Surgery
🇺🇸Charleston, South Carolina, United States
Texas Oncology - Austin
🇺🇸Austin, Texas, United States
Luminis Health Center for Cancer & Blood Disorders
🇺🇸Annapolis, Maryland, United States
Mercy Medical Center
🇺🇸Springfield, Massachusetts, United States
Maryland Oncology Hematology - Clinton
🇺🇸Clinton, Maryland, United States
Maryland Oncology Hematology, PA
🇺🇸Silver Spring, Maryland, United States
Frederick Oncology Hematology Associates
🇺🇸Frederick, Maryland, United States
Maryland Oncology Hematology - Aquilino Cancer Center
🇺🇸Rockville, Maryland, United States
Lake Success Oncology / ProHealth Care
🇺🇸Lake Success, New York, United States
Cancer Centers of Southwest Oklahoma
🇺🇸Lawton, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
West Cancer Center
🇺🇸Germantown, Tennessee, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Texas Oncology - Flower Mound
🇺🇸Flower Mound, Texas, United States
University of Texas Medical Branch
🇺🇸League City, Texas, United States
Texas Oncology - Webster
🇺🇸Webster, Texas, United States
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada