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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
2035-12
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
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 (15)
Arizona Center for Cancer Care
Phoenix, Arizona, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Mills-Peninsula Medical Center
San Mateo, California, United States
University of Colorado Denver
Aurora, Colorado, United States
UC Health - Memorial Hospital, Colorado Springs
Colorado Springs, Colorado, United States
St. Joseph's Hospital Tampa
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States
Comprehensive Breast Care
Troy, Michigan, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Nashville Breast Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States