RecruitingDCISStage 0 Breast CancerDuctal Breast Carcinoma In Situ
The PREDICT Registry:
Eligible age
30–85 yrs
Accepts
Women
Locations
16 states
Healthy volunteers
No
See if you qualify for this study
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About this 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.
Sponsor: PreludeDx
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT03448926 · last updated 2026-04-17