The PREDICT Registry:

Recruiting now

Conditions studied: DCIS, Stage 0 Breast Cancer, Ductal Breast Carcinoma In Situ

In brief

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.

Key facts

Study ID

NCT03448926

Run by

PreludeDx

People needed

3000

Starts

2018-02-27

Expected to finish

2036-12-01

Last updated by the study team

2026-04-17

Who can join

Age: 30 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Patient must have the DCISionRT test ordered during routine patient care.
• Patient must be eligible for or have recently completed breast conserving surgery.
• Patient must be eligible to receive radiation and/or systemic treatment.
• Patient must be 30 to 85 years old.
• Patient must have tumor size of less than 6 cm.
• Patient must have been diagnosed with DCIS within 120 days of consent.

You may not qualify if…

• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
• 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.
• Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
• Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
• Patient has a prior history of in-field radiation in the ipsilateral breast.
• Patient has had prior systemic endocrine or chemotherapy prior to testing.
• Patient is pregnant.

Where it is running

• Arizona Center for Cancer Care — Scottsdale, Arizona, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• Sutter Health — San Mateo, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
• BayCare Health System — Tampa, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Endeavor Health (Northshore) — Evanston, Illinois, United States (enrolling)
• MedStar Health Research Institute — Baltimore, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Corewell Health William Beaumont University Center — Royal Oak, Michigan, United States (enrolling)
• Comprehensive Breast Care — Troy, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Maimonides Cancer Center — Brooklyn, New York, United States (enrolling)
• Northwell Health Center for Advanced Medicine — Lake Success, New York, United States (enrolling)
• NYU - Long Island — Mineola, New York, United States (enrolling)
• NYU - Manhattan — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Cleveland Clinic Akron General — Akron, Ohio, United States (enrolling)
• Cleveland Clinic Foundation-Taussig Cancer Inst — Cleveland, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Compass Oncology — Tigard, Oregon, United States (enrolling)
• St Luke's University Health Network — Easton, Pennsylvania, United States (enrolling)
• Sidney Kimmel Comprehensive Cancer Ctr - Jefferson — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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