The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

Launched by PRELUDEDX · Jun 1, 2021

Keywords

ClinConnect Summary

The AUS-PREDICT Registry study is looking at how a specific test called DCISionRT™ can help doctors make better treatment decisions for women with ductal carcinoma in situ (DCIS), a non-invasive type of breast cancer. The goal is to create a database that collects information about patients, their test results, treatments, and outcomes, which can help understand how useful this test is in managing DCIS.

To be eligible for the study, participants must be women over 25 years old who have been diagnosed with DCIS in one breast and are planning to undergo treatment, including breast-conserving surgery. They also need to agree to participate within 120 days after their surgery. If you join the study, your information will be kept private, and you’ll be helping researchers learn more about DCIS and how to improve care for future patients.

Gender

FEMALE

Eligibility criteria

• 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