Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03448926

The PREDICT Registry:

Sponsor: PreludeDx

View on ClinicalTrials.gov

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

OTHER

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.

DEVICE

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