A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
PreludeDx
Summary
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.
Description
After a diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3-4 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen should be selected from tissue collected via direct tumor biopsy (either core needle or excisional biopsy) as part of routine patient care. Patients must be enrolled in the study and the enrollment and pre-testing data forms must be completed and submitted before the DCISionRT results are reported. Then, after review of the DCISionRT results, the investigators complete and submit the post-testing…