RECRUITING

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

Talk to us

Conditions

Breast Cancerstage Istage IIstage III

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-04-28
Study Completion:2037-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03053193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
  2. * Informed consent form signed on the same day or before enrollment
  3. * New primary lesion
  1. * Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  2. * Metastatic disease
  3. * Recurrent disease
  4. * Stage 0 disease

Contacts and Locations

Study Contact

Christine Carruth
CONTACT
517-242-4181
christine.carruth@agendia.com

Principal Investigator

William Audeh, MD
STUDY_DIRECTOR
Agendia, Inc.
Joyce O'Shaughnessy, MD
PRINCIPAL_INVESTIGATOR
Texas Oncology - Baylor Charles A. Sammons Center

Study Locations (Sites)

CHS Grandview
Birmingham, Alabama, 35243
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Arizona Oncology Associates, PC
Phoenix, Arizona, 85006
United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704
United States
Adventist Health - Bakersfield
Bakersfield, California, 93301
United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
United States
North Valley Breast Clinic
Redding, California, 96001
United States
UCSF Breast Care Center
San Francisco, California, 94158
United States
Valley Breast Care
Van Nuys, California, 91405
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Comprehensive Breast Care of Denver
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Center - Lakewood
Lakewood, Colorado, 80228
United States
Vail Health - Shaw Cancer Center
Vail, Colorado, 81658
United States
St. Mary's Hospital
Waterbury, Connecticut, 06706
United States
Medical Oncology and Hematology Consultants
Newark, Delaware, 19713
United States
Breast Specialists of South Florida
Atlantis, Florida, 33462
United States
JFK Medical Center
Atlantis, Florida, 33462
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33428
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
Halifax Health - Center for Oncology
Daytona Beach, Florida, 32114
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
University of Florida - Jacksonville
Jacksonville, Florida, 32224
United States
St. Vincent Hospital / Mayo Clinic
Jacksonville, Florida, 32256
United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
United States
Sylvester Comprehensive Cancer Center - University of Miami
Miami, Florida, 33136
United States
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176
United States
Cancer Care Centers of Brevard
Rockledge, Florida, 32955
United States
St. Joseph's Hospital - Baycare
Tampa, Florida, 33607
United States
University of South Florida
Tampa, Florida, 33613
United States
Winter Haven Hospital
Winter Haven, Florida, 33881
United States
Phoebe Health
Albany, Georgia, 31701
United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318
United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Southeast Georgia Health System - Physician Associates
Brunswick, Georgia, 31520
United States
DeKalb Medical Center
Decatur, Georgia, 30033
United States
Candler Hospital
Savannah, Georgia, 31405
United States
Tift Regional Health System
Tifton, Georgia, 31794
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Saint Alexius Medical Center
Hoffman Estates, Illinois, 60169
United States
Affiliated Oncologists
Oak Lawn, Illinois, 60453
United States
Parkview Health
Fort Wayne, Indiana, 46805
United States
Louisiana State University
Shreveport, Louisiana, 71103
United States
Northern Light Breast Care
Portland, Maine, 04102
United States
Luminis Health Center for Cancer & Blood Disorders
Annapolis, Maryland, 21401
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231
United States
Maryland Oncology Hematology - Bethesda
Bethesda, Maryland, 20817
United States
Maryland Oncology Hematology - Brandywine
Brandywine, Maryland, 20613
United States
Maryland Oncology Hematology - Clinton
Clinton, Maryland, 20735
United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044
United States
UPMC at Western Maryland Health System
Cumberland, Maryland, 21502
United States
Frederick Oncology Hematology Associates
Frederick, Maryland, 21702
United States
Maryland Oncology Hematology - Aquilino Cancer Center
Rockville, Maryland, 20850
United States
Maryland Oncology Hematology, PA
Silver Spring, Maryland, 20904
United States
Mercy Medical Center
Springfield, Massachusetts, 01104
United States
St. John Hospital
Grosse Pointe Woods, Michigan, 48236
United States
Sparrow Cancer Center
Lansing, Michigan, 48912
United States
Beaumont Breast Care Center
Royal Oak, Michigan, 48076
United States
Providence - Providence Park Hospital
Southfield, Michigan, 48075
United States
Comprehensive Breast Care
Troy, Michigan, 48098
United States
Minnesota Oncology
Minneapolis, Minnesota, 55404
United States
Boone Hospital Center
Columbia, Missouri, 65201
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
New York Oncology Hematology
Albany, New York, 12206
United States
Broome Oncology
Binghamton, New York, 13905
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Lake Success Oncology / ProHealth Care
Lake Success, New York, 11020
United States
NYU Winthrop Hospital
Mineola, New York, 11501
United States
Northwell Health- Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
Kings County Hospital
New York, New York, 10004
United States
Hematology Oncology Center of Rockland at Nyack
Nyack, New York, 10960
United States
University of Rochester - Pluta Cancer Center
Rochester, New York, 14642
United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
United States
Northwell Health- Phelps Hospital
Tarrytown, New York, 10591
United States
Akron General Medical Center
Akron, Ohio, 44307
United States
TriHealth Cancer Institutes
Cincinnati, Ohio, 45220
United States
Oncology Hematology Care
Cincinnati, Ohio, 45236
United States
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505
United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
United States
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
United States
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008
United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, 15213
United States
Grandview Hospital
Sellersville, Pennsylvania, 18960
United States
Roper St. Francis Physician Partners - Breast Surgery
Charleston, South Carolina, 29401
United States
Tidelands Health Coastal Carolina Breast Center
Georgetown, South Carolina, 29442
United States
West Cancer Center
Germantown, Tennessee, 38138
United States
Nashville Breast Center
Nashville, Tennessee, 37203
United States
Texas Oncology - Allen
Allen, Texas, 75013
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Texas Oncology - Austin
Austin, Texas, 78731
United States
Texas Oncology - Bedford
Bedford, Texas, 76022
United States
Texas Oncology - Carrollton
Carrollton, Texas, 75010
United States
CHRISTUS Spohn Cancer Center
Corpus Christi, Texas, 78404
United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, 75203
United States
Texas Oncology - Presbyterian
Dallas, Texas, 75231
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
Texas Oncology - Denton
Denton, Texas, 76210
United States
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028
United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
United States
Texas Oncology - Grapevine
Grapevine, Texas, 76051
United States
Texas Oncology - Memorial City
Houston, Texas, 77024
United States
Texas Oncology Willowbrook
Houston, Texas, 77070
United States
Oncology Consultants
Katy, Texas, 77494
United States
University of Texas Medical Branch
League City, Texas, 77573
United States
Texas Oncology - Longview
Longview, Texas, 75601
United States
Texas Tech UHSC - Southwest Cancer Center
Lubbock, Texas, 79430
United States
Texas Oncology - McKinney
McKinney, Texas, 75071
United States
Texas Oncology - Plano East
Plano, Texas, 75075
United States
Texas Oncology - Plano West
Plano, Texas, 95093
United States
Texas Oncology, PA - Metropolitan
San Antonio, Texas, 78212
United States
Texas Oncology, PA - Northeast
San Antonio, Texas, 78217
United States
UT Health Cancer Center
San Antonio, Texas, 78229
United States
Texas Oncology PA -San Antonio Medical Center
San Antonio, Texas, 78240
United States
Texas Oncology, PA - Stone Oak
San Antonio, Texas, 78258
United States
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479
United States
Texas Oncology - Tyler
Tyler, Texas, 75702
United States
Texas Oncology - Waco
Waco, Texas, 76712
United States
Texas Oncology - Webster
Webster, Texas, 77584
United States
Ogden Regional Cancer Center
Ogden, Utah, 84405
United States
Skagit Valley Hospital
Mount Vernon, Washington, 98273
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Columbia St. Mary's
Milwaukee, Wisconsin, 53211
United States

Collaborators and Investigators

Sponsor: Agendia

  • William Audeh, MD, STUDY_DIRECTOR, Agendia, Inc.
  • Joyce O'Shaughnessy, MD, PRINCIPAL_INVESTIGATOR, Texas Oncology - Baylor Charles A. Sammons Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-28
Study Completion Date2037-12

Study Record Updates

Study Start Date2017-04-28
Study Completion Date2037-12

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • stage I
  • stage II
  • stage III

Additional Relevant MeSH Terms

  • Breast Cancer