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…
Eligibility
- Age range
- 30–85 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- OtherTreatment recommendation surveys
Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.
- Device7-gene biosignature
Ordering the 7-gene biosignature assay (DCISionRT) as a part of routine care for DCIS is a prerequisite (inclusion criterion) for the study. The study is not designed to determine the efficacy of the assay, rather it is designed to meausre the impact of the assay results on treatment decisions for patients with DCIS.
Locations (30)
- Arizona Center for Cancer CareScottsdale, Arizona
- University of California San DiegoLa Jolla, California
- Sutter HealthSan Mateo, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Baptist MD Anderson Cancer CenterJacksonville, Florida
- BayCare Health SystemTampa, Florida