A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with Ductal Carcinoma In Situ (DCIS) Following Breast Conserving Therapy to Determine the Clinical Utility of the DCISionRT Test in the Management of DCIS

After diagnosis of DCIS, sites will send the most representative tissue block (or sections mounted on charged slides) to PreludeDx for genetic testing using the DCISionRT test. 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 with completion of a follow-up form. Data captured pre and post-test will be captured in the registry along with follow up information and contribute to further hypothesis generation. Participants will be provided with an patient information consent form as well as DCISionRT brochure and verbal information from their treating doctor. The informed consent process and registry specific activities involving the participants will be carried out face-to-face by breast cancer surgeons and/or radiation oncologists depending on site processes. The DCISionRT test will be ordered and carried out once only for each participant. This will be done at private or public breast cancer and radiation oncology clinics. Routine Care Procedures (not part of the research): 1. Diagnosis of DCIS will be performed according to the standard of care at the participating institution and/or its referring clinical facilities. 2. The DCISionRT test will be ordered by completing the standard requisition form. The most representative tissue specimen will be selected by collaboration between the PreludeDx lab and local pathology lab as specified by work instructions for block selection and slide preparation as usual. 3. The PreludeDx lab will perform testing and reporting using the same protocols as for non-research samples, except for the addition of a study ID as defined below. Study-Specific Procedures: The sponsor and/or its agents will provide training to each participating center. 1. Investigators and/or study staff will pre-screen patients who have had DCISionRT testing ordered (or are in the process of being ordered) and select patients for possible enrollment. During pre-screening, existing patient medical records will be examined only to the extent necessary to determine whether the patient meets the eligibility criteria. No additional testing outside of routine clinical care is required to determine patient eligibility. 2. Informed consent will be carried out according to the local institutional policies. Once the informed consent has been provided by the patient, the patient is considered enrolled and there are no additional screening procedures or study-specific visits required. 3. Once the patient has provided informed consent, study staff will obtain a unique Study ID from the online registry and record this on the screening and enrollment log. Patients found to meet any exclusion criteria at any time will be excluded from the study. 4. A link between the Study ID and the patient’s identity must be maintained locally, preferably using the screening and enrollment log. 5. Study staff will either write the Study ID on the DCISionRT requisition form or notify the PreludeDx clinical lab that the patient is enrolled in the study so that the Study ID can be associated with the patient in the lab information system (LIS). 6. The Enrollment and Demographics (CRF1) and Pre-DCISionRT Treatment Recommendations Form (CRF2) will be completed with patient enrollment information and the treating physician or tumor board pre-test treatment recommendation, before the DCISionRT results are reported to the treating physician and study staff 7. In addition to routine reporting of DCISionRT results (either by fax or the PreludeDx online portal), DCISionRT results will be automatically transmitted to the de-identified online registry. The treating physician or tumor board will complete the Post-test Treatment Recommendations Form (CRF3) as soon as possible after the DCISionRT results have been reported.