DCIS Clinical Trial
Official title:
Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
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
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.
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