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The PREDICT Registry:

Sponsored by PreludeDx

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.

After a diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3-4 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen should be selected from tissue collected via direct tumor biopsy (either core needle or excisional biopsy) as part of routine patient care. Patients must be enrolled in the study and the enrollment and pre-testing data forms must be completed and submitted before the DCISionRT results are reported. Then, after review of the DCISionRT results, the investigators complete and submit the post-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of 5- and 10-year follow-up forms. All study data will be stored in an encrypted, HIPAA-compliant datab…

Where this study is enrolling (30)

Show all 30 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.