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The PREDICT Registry:

RecruitingObservational study

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

Who can join

Ages 30 to 85 · Women

Full eligibility criteria
Inclusion criteria

1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
2. Patient must have the DCISionRT test ordered during routine patient care.
3. Patient must be eligible for or have recently completed breast conserving surgery.
4. Patient must be eligible to receive radiation and/or systemic treatment.
5. Patient must be 30 to 85 years old.
6. Patient must have tumor size of less than 6 cm.
7. Patient must have been diagnosed with DCIS within 120 days of consent.

Exclusion criteria

1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
5. Patient has a prior history of in-field radiation in the ipsilateral breast.
6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
7. Patient is pregnant.

About the study

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.

What is being tested

Sponsor: PreludeDx · Participants: 3,000 · Started: Feb 27, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT03448926

Locations in the U.S.

ArizonaArizona Center for Cancer Care, Scottsdale
CaliforniaUniversity of California San Diego, La Jolla
Sutter Health, San Mateo
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
FloridaBaptist MD Anderson Cancer Center, Jacksonville
BayCare Health System, Tampa
University of South Florida, Tampa
GeorgiaEmory University Winship Cancer Institute, Atlanta
IllinoisEndeavor Health (Northshore), Evanston
MarylandMedStar Health Research Institute, Baltimore
MassachusettsDana-Farber Cancer Institute, Boston
MichiganCorewell Health William Beaumont University Center, Royal Oak
Comprehensive Breast Care, Troy
MissouriWashington University School of Medicine, St Louis
New YorkMaimonides Cancer Center, Brooklyn
Northwell Health Center for Advanced Medicine, Lake Success
NYU - Long Island, Mineola
Columbia University Medical Center, New York
NYU - Manhattan, New York
OhioCleveland Clinic Akron General, Akron
Cleveland Clinic Foundation-Taussig Cancer Inst, Cleveland
The Ohio State University, Columbus
OregonCompass Oncology, Tigard
PennsylvaniaSt Luke's University Health Network, Easton
Sidney Kimmel Comprehensive Cancer Ctr - Jefferson, Philadelphia
AHN Allegheny General Hospital, Pittsburgh
TennesseeNashville Breast Center, Nashville
TexasUT Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Texas Oncology, Plano

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.