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

NCT03053193 · Agendia
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Official title
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 30000 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-04-28
Estimated completion: 2037-12
Last updated: 2025-08-20
Interventions
Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Primary outcomes
  • 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)
  • A shared registry infrastructure to examine smaller groups of interest. (10 years)
Sponsor
Agendia · industry
Contacts & investigators
ContactMichelle Landon, MS, CGC · contact · michelle.landon@agendia.com · 801-633-8215
InvestigatorWilliam Audeh, MD · study_director, Agendia, Inc.
InvestigatorJoyce O'Shaughnessy, MD · principal_investigator, Texas Oncology - Baylor Charles A. Sammons Center
All locations (134)
CHS GrandviewCompleted
Birmingham, Alabama, United States
Providence Alaska Medical CenterRecruiting
Anchorage, Alaska, United States
Arizona Oncology Associates, PCRecruiting
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPERecruiting
Tucson, Arizona, United States
Adventist Health - BakersfieldRecruiting
Bakersfield, California, United States
Comprehensive Cancer Center at Desert Regional Medical CenterRecruiting
Palm Springs, California, United States
North Valley Breast ClinicRecruiting
Redding, California, United States
UCSF Breast Care CenterRecruiting
San Francisco, California, United States
Valley Breast CareRecruiting
Van Nuys, California, United States
Rocky Mountain Cancer CentersRecruiting
Aurora, Colorado, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Comprehensive Breast Care of DenverRecruiting
Denver, Colorado, United States
Rocky Mountain Cancer Center - LakewoodRecruiting
Lakewood, Colorado, United States
Vail Health - Shaw Cancer CenterRecruiting
Vail, Colorado, United States
St. Mary's HospitalRecruiting
Waterbury, Connecticut, United States
Medical Oncology and Hematology ConsultantsRecruiting
Newark, Delaware, United States
Breast Specialists of South FloridaRecruiting
Atlantis, Florida, United States
JFK Medical CenterRecruiting
Atlantis, Florida, United States
Boca Raton Regional HospitalRecruiting
Boca Raton, Florida, United States
Morton Plant HospitalRecruiting
Clearwater, Florida, United States
Halifax Health - Center for OncologyRecruiting
Daytona Beach, Florida, United States
Baptist MD Anderson Cancer CenterRecruiting
Jacksonville, Florida, United States
University of Florida - JacksonvilleCompleted
Jacksonville, Florida, United States
St. Vincent Hospital / Mayo ClinicActive Not Recruiting
Jacksonville, Florida, United States
Lakeland Regional Cancer CenterRecruiting
Lakeland, Florida, United States
Sylvester Comprehensive Cancer Center - University of MiamiRecruiting
Miami, Florida, United States
Miami Cancer Institute at Baptist Health, IncRecruiting
Miami, Florida, United States
Cancer Care Centers of BrevardRecruiting
Rockledge, Florida, United States
St. Joseph's Hospital - BaycareRecruiting
Tampa, Florida, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Winter Haven HospitalRecruiting
Winter Haven, Florida, United States
Phoebe HealthRecruiting
Albany, Georgia, United States
Piedmont Cancer InstituteRecruiting
Atlanta, Georgia, United States
Emory University - Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Southeast Georgia Health System - Physician AssociatesRecruiting
Brunswick, Georgia, United States
DeKalb Medical CenterCompleted
Decatur, Georgia, United States
Candler HospitalRecruiting
Savannah, Georgia, United States
Tift Regional Health SystemRecruiting
Tifton, Georgia, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Alexian Brothers Medical CenterRecruiting
Elk Grove Village, Illinois, United States
Saint Alexius Medical CenterRecruiting
Hoffman Estates, Illinois, United States
Affiliated OncologistsRecruiting
Oak Lawn, Illinois, United States
Parkview HealthRecruiting
Fort Wayne, Indiana, United States
Louisiana State UniversityRecruiting
Shreveport, Louisiana, United States
Northern Light Breast CareRecruiting
Portland, Maine, United States
Luminis Health Center for Cancer & Blood DisordersRecruiting
Annapolis, Maryland, United States
Mercy Medical CenterRecruiting
Baltimore, Maryland, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Maryland Oncology Hematology - BethesdaRecruiting
Bethesda, Maryland, United States
Maryland Oncology Hematology - BrandywineRecruiting
Brandywine, Maryland, United States
Maryland Oncology Hematology - ClintonRecruiting
Clinton, Maryland, United States
Maryland Oncology Hematology, PARecruiting
Columbia, Maryland, United States
UPMC at Western Maryland Health SystemRecruiting
Cumberland, Maryland, United States
Frederick Oncology Hematology AssociatesRecruiting
Frederick, Maryland, United States
Maryland Oncology Hematology - Aquilino Cancer CenterRecruiting
Rockville, Maryland, United States
Maryland Oncology Hematology, PARecruiting
Silver Spring, Maryland, United States
Mercy Medical CenterCompleted
Springfield, Massachusetts, United States
St. John HospitalRecruiting
Grosse Pointe Woods, Michigan, United States
Sparrow Cancer CenterRecruiting
Lansing, Michigan, United States
Beaumont Breast Care CenterRecruiting
Royal Oak, Michigan, United States
Providence - Providence Park HospitalCompleted
Southfield, Michigan, United States
Comprehensive Breast CareRecruiting
Troy, Michigan, United States
Minnesota OncologyRecruiting
Minneapolis, Minnesota, United States
Boone Hospital CenterCompleted
Columbia, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
New York Oncology HematologyRecruiting
Albany, New York, United States
Broome OncologyCompleted
Binghamton, New York, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Lake Success Oncology / ProHealth CareCompleted
Lake Success, New York, United States
NYU Winthrop HospitalRecruiting
Mineola, New York, United States
Northwell Health- Northern Westchester HospitalRecruiting
Mount Kisco, New York, United States
Kings County HospitalRecruiting
New York, New York, United States
Hematology Oncology Center of Rockland at NyackRecruiting
Nyack, New York, United States
University of Rochester - Pluta Cancer CenterRecruiting
Rochester, New York, United States
SUNY Upstate Medical University HospitalRecruiting
Syracuse, New York, United States
Northwell Health- Phelps HospitalRecruiting
Tarrytown, New York, United States
Akron General Medical CenterRecruiting
Akron, Ohio, United States
TriHealth Cancer InstitutesRecruiting
Cincinnati, Ohio, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Cancer Centers of Southwest OklahomaCompleted
Lawton, Oklahoma, United States
Willamette Valley Cancer Institute and Research CenterRecruiting
Eugene, Oregon, United States
Legacy Good Samaritan Medical CenterRecruiting
Portland, Oregon, United States
Oregon Health Sciences UniversityCompleted
Portland, Oregon, United States
St. Luke's HospitalRecruiting
Bethlehem, Pennsylvania, United States
Consultants in Medical Oncology and Hematology, P.C.Recruiting
Broomall, Pennsylvania, United States
Alliance Cancer SpecialistsRecruiting
Horsham, Pennsylvania, United States
St. Mary Medical CenterTerminated
Langhorne, Pennsylvania, United States
Allegheny Health NetworkRecruiting
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical CentersRecruiting
Pittsburgh, Pennsylvania, United States
Grandview HospitalCompleted
Sellersville, Pennsylvania, United States
Roper St. Francis Physician Partners - Breast SurgeryRecruiting
Charleston, South Carolina, United States
Tidelands Health Coastal Carolina Breast CenterRecruiting
Georgetown, South Carolina, United States
West Cancer CenterRecruiting
Germantown, Tennessee, United States
Nashville Breast CenterRecruiting
Nashville, Tennessee, United States
Texas Oncology - AllenRecruiting
Allen, Texas, United States
Harrington Cancer CenterCompleted
Amarillo, Texas, United States
Texas Oncology - AustinRecruiting
Austin, Texas, United States
Texas Oncology - BedfordRecruiting
Bedford, Texas, United States
Texas Oncology - CarrolltonRecruiting
Carrollton, Texas, United States
CHRISTUS Spohn Cancer CenterRecruiting
Corpus Christi, Texas, United States
Texas Oncology - Methodist Dallas Cancer CenterCompleted
Dallas, Texas, United States
Texas Oncology - PresbyterianRecruiting
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Texas Oncology - DentonRecruiting
Denton, Texas, United States
Texas Oncology - Flower MoundRecruiting
Flower Mound, Texas, United States
The Center for Cancer and Blood DisordersCompleted
Fort Worth, Texas, United States
Texas Oncology - GrapevineRecruiting
Grapevine, Texas, United States
Texas Oncology - Memorial CityRecruiting
Houston, Texas, United States
Texas Oncology WillowbrookRecruiting
Houston, Texas, United States
Oncology ConsultantsCompleted
Katy, Texas, United States
University of Texas Medical BranchRecruiting
League City, Texas, United States
Texas Oncology - LongviewRecruiting
Longview, Texas, United States
Texas Tech UHSC - Southwest Cancer CenterRecruiting
Lubbock, Texas, United States
Texas Oncology - McKinneyRecruiting
McKinney, Texas, United States
Texas Oncology - Plano EastRecruiting
Plano, Texas, United States
Texas Oncology - Plano WestRecruiting
Plano, Texas, United States
Texas Oncology, PA - MetropolitanRecruiting
San Antonio, Texas, United States
Texas Oncology, PA - NortheastRecruiting
San Antonio, Texas, United States
UT Health Cancer CenterRecruiting
San Antonio, Texas, United States
Texas Oncology PA -San Antonio Medical CenterRecruiting
San Antonio, Texas, United States
Texas Oncology, PA - Stone OakRecruiting
San Antonio, Texas, United States
Texas Oncology - Sugar LandRecruiting
Sugar Land, Texas, United States
Texas Oncology - TylerRecruiting
Tyler, Texas, United States
Texas Oncology - WacoRecruiting
Waco, Texas, United States
Texas Oncology - WebsterRecruiting
Webster, Texas, United States
Ogden Regional Cancer CenterRecruiting
Ogden, Utah, United States
Skagit Valley HospitalRecruiting
Mount Vernon, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Seattle Cancer Care AllianceRecruiting
Seattle, Washington, United States
Columbia St. Mary'sRecruiting
Milwaukee, Wisconsin, United States
William Osler Cancer CentreRecruiting
Brampton, Ontario, Canada
Thunder Bay Regional Health Sciences CentreRecruiting
Thunder Bay, Ontario, Canada
University General Hospital AlexandraRecruiting
Athens, Greece
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles · TrialPath