The PREDICT Registry:

Launched by PRELUDEDX · Feb 27, 2018

Keywords

ClinConnect Summary

The PREDICT Registry is a clinical study focusing on women who have been diagnosed with ductal carcinoma in situ (DCIS), a type of non-invasive breast cancer. This study aims to gather information about patients who meet specific criteria, including those who are between 30 and 85 years old, have confirmed DCIS in one breast, and are candidates for breast-conserving surgery and possibly radiation therapy. Participants will need to provide consent and will have their health monitored over time to help understand the best treatment options for DCIS.

To be eligible for this study, women must have their DCIS confirmed through a tissue test and must not have a history of invasive breast cancer or certain other conditions. If you join the study, you can expect to undergo the standard care process, including the DCISionRT test, which helps guide treatment decisions. The PREDICT Registry is currently recruiting participants, and your involvement could contribute to valuable insights that may improve treatment for future patients with DCIS.

Gender

FEMALE

Eligibility criteria

• • 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.