RecruitingNCT03448926

The PREDICT Registry:

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy


Sponsor

PreludeDx

Enrollment

3,000 participants

Start Date

Feb 27, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This registry is tracking outcomes for patients with a non-invasive form of breast cancer called DCIS (ductal carcinoma in situ) who have had the DCISionRT genomic test ordered, to help doctors understand which patients truly need radiation therapy after surgery. **You may be eligible if...** - You have been diagnosed with DCIS in one breast (non-invasive breast cancer) - The DCISionRT genomic test has been ordered as part of your routine care - You are eligible for or have recently completed breast-conserving surgery (lumpectomy) - You are between 30 and 85 years old - Your tumor is smaller than 6 cm **You may NOT be eligible if...** - Your DCIS is in both breasts - You are under 30 or over 85 years old - Your tumor is 6 cm or larger - You are not a candidate for radiation or systemic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTreatment 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.

DEVICE7-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

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NCT03448926


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