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Summary
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.
Official title: A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
Key Details
Gender
FEMALE
Age Range
30 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2018-02-27
Completion Date
2036-12
Last Updated
2026-04-17
Healthy Volunteers
No
Interventions
Treatment recommendation surveys
Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.
7-gene biosignature
Ordering the 7-gene biosignature assay (DCISionRT) as a part of routine care for DCIS is a prerequisite (inclusion criterion) for the study. The study is not designed to determine the efficacy of the assay, rather it is designed to meausre the impact of the assay results on treatment decisions for patients with DCIS.
Locations (30)
Arizona Center for Cancer Care
Scottsdale, Arizona, United States
University of California San Diego
La Jolla, California, United States
Sutter Health
San Mateo, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
BayCare Health System
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Endeavor Health (Northshore)
Evanston, Illinois, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Corewell Health William Beaumont University Center
Royal Oak, Michigan, United States
Comprehensive Breast Care
Troy, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Northwell Health Center for Advanced Medicine
Lake Success, New York, United States
NYU - Long Island
Mineola, New York, United States
NYU - Manhattan
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Cleveland Clinic Foundation-Taussig Cancer Inst
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Compass Oncology
Tigard, Oregon, United States
St Luke's University Health Network
Easton, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Ctr - Jefferson
Philadelphia, Pennsylvania, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Nashville Breast Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Oncology
Plano, Texas, United States