Spots Global Cancer Trial Database for Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
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Trial Identification
Brief Title: Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Official Title: Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features
Study ID: NCT04797299
Conditions
Interventions
Study Description
Brief Summary: To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)
Detailed Description: A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study. 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. A two-step registration/enrollment process will be implemented. Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.
Eligibility
Minimum Age: 46 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer - Centre for the North (Prince George), Prince George, British Columbia, Canada
BC Cancer - Vancouver Centre, Vancouver, British Columbia, Canada
BC Cancer - Victoria, Victoria, British Columbia, Canada
QE II HSC - Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre, Sydney, Nova Scotia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Regional Cancer Care, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Sunnybrook Health Science Centre -Odette Cancer Centre, Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre), Greenfield Park, Quebec, Canada
CHUM - Centre Hospitalier de L'Université de Montréal, Montreal, Quebec, Canada
Jewish General Hospital, Montréal, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec - Université Laval, Québec City, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières, Trois-Rivières, Quebec, Canada
Contact Details
Name: Eileen Rakovitch, M.D.
Affiliation: Sunnybrook Research Institute, Sunnybrook Health Science
Role: PRINCIPAL_INVESTIGATOR
Name: Tim Whelan, M.D
Affiliation: Juravinski Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
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