The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

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.

Eligibility

Inclusion Criteria:

1. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
2. 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)
3. Patient must be consented within 120 days after surgery
4. Patient must be eligible for, or have already received breast conserving surgery
5. Patient must be eligible to receive radiation and/or systemic treatment
6. Patient must be female and greater than 25 years old
7. Patient must be able to provide informed 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 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
3. Patient has already been surgically treated with a mastectomy for primary DCIS
4. Patient has prior in situ or invasive breast cancer

Conditions3

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