NCT02766881

Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS

Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 281 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: 46 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery

Detailed description

A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score. At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.

Conditions

• DCIS

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-06-13
• Completion: 2019-09-30
• First posted: 2016-05-10
• Last updated: 2020-02-19

Locations

12 sites across 1 country: Canada