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Spots Global Cancer Trial Database for MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Study ID: NCT03053193

Conditions

Breast Cancer

Study Description

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 25,000 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHS Grandview, Birmingham, Alabama, United States

Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, 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

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

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

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

Providence - Providence Park Hospital, Southfield, Michigan, United States

Comprehensive Breast Care, Troy, Michigan, United States

Minnesota Oncology, Minneapolis, Minnesota, United States

Boone Hospital Center, Columbia, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

New York Oncology Hematology, Albany, New York, United States

Broome Oncology, Binghamton, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Lake Success Oncology / ProHealth Care, Lake Success, New York, United States

NYU Winthrop Hospital, Mineola, New York, United States

Northwell Health- Northern Westchester Hospital, Mount Kisco, New York, United States

Hematology Oncology Center of Rockland at Nyack, Nyack, New York, United States

University of Rochester - Pluta Cancer Center, Rochester, New York, United States

SUNY Upstate Medical University Hospital, Syracuse, New York, United States

Northwell Health- Phelps Hospital, Tarrytown, New York, United States

Akron General Medical Center, Akron, Ohio, United States

TriHealth Cancer Institutes, Cincinnati, Ohio, United States

Oncology Hematology Care, Cincinnati, Ohio, United States

Cancer Centers of Southwest Oklahoma, Lawton, Oklahoma, United States

Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States

Oregon Health Sciences University, Portland, Oregon, United States

St. Luke's Hospital, Bethlehem, Pennsylvania, United States

Alliance Cancer Specialists, Horsham, Pennsylvania, United States

St. Mary Medical Center, Langhorne, Pennsylvania, United States

Allegheny Health Network, Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Centers, Pittsburgh, Pennsylvania, United States

Grandview Hospital, Sellersville, Pennsylvania, United States

Roper St. Francis Physician Partners - Breast Surgery, Charleston, South Carolina, United States

Tidelands Health Coastal Carolina Breast Center, Georgetown, South Carolina, United States

West Cancer Center, Germantown, Tennessee, United States

Nashville Breast Center, Nashville, Tennessee, United States

Texas Oncology - Allen, Allen, Texas, United States

Harrington Cancer Center, Amarillo, Texas, United States

Texas Oncology - Bedford, Bedford, Texas, United States

Texas Oncology - Carrollton, Carrollton, Texas, United States

CHRISTUS Spohn Cancer Center, Corpus Christi, Texas, United States

Texas Oncology - Methodist Dallas Cancer Center, Dallas, Texas, United States

Texas Oncology - Presbyterian, Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

Texas Oncology - Denton, Denton, Texas, United States

Texas Oncology - Flower Mound, Flower Mound, Texas, United States

The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

Texas Oncology - Grapevine, Grapevine, Texas, United States

Texas Oncology - Memorial City, Houston, Texas, United States

Oncology Consultants, Katy, Texas, United States

University of Texas Medical Branch, League City, Texas, United States

Texas Oncology - Longview, Longview, Texas, United States

Texas Tech UHSC - Southwest Cancer Center, Lubbock, Texas, United States

Texas Oncology - McKinney, McKinney, Texas, United States

Texas Oncology - Plano East, Plano, Texas, United States

Texas Oncology - Plano West, Plano, Texas, 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

Texas Oncology - Tyler, Tyler, Texas, United States

Texas Oncology - Waco, Waco, Texas, United States

Texas Oncology - Webster, Webster, Texas, United States

Ogden Regional Cancer Center, Ogden, Utah, United States

Skagit Valley Hospital, Mount Vernon, Washington, United States

Swedish Cancer Institute, Seattle, Washington, United States

Seattle Cancer Care Alliance, Seattle, Washington, United States

Columbia St. Mary's, Milwaukee, Wisconsin, United States

University General Hospital Alexandra, Athens, , Greece

Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel

Contact Details

Name: William Audeh, MD

Affiliation: Agendia, Inc.

Role: STUDY_DIRECTOR

Name: Cynthia X Ma, MD

Affiliation: Washington University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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