Active — Not RecruitingNot Applicable

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

Australia1,500 participantsStarted 2021-07-02

Plain-language summary

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

Who can participate

Age range26 Years

SexFEMALE

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Inclusion criteria

✓. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
✓. 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 be consented within 120 days after surgery
✓. Patient must be eligible for, or have already received breast conserving surgery
✓. Patient must be eligible to receive radiation and/or systemic treatment
✓. Patient must be female and greater than 25 years old
✓. Patient must be able to provide informed consent

Exclusion criteria

✕. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing
✕. Patient has invasive breast cancer or evidence in the ipsilateral or contralateral breast of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple
✕. Patient has already been surgically treated with a mastectomy for primary DCIS
✕. Patient has prior in situ or invasive breast cancer

What they're measuring

Percent of Cases with Changes in Treatment Recommendation

Timeframe: 5 years

Trial details

NCT IDNCT04916808

SponsorPreludeDx

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-30

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