Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
NCT ID: NCT04797299
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
526 participants
OBSERVATIONAL
2022-11-23
2035-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single Arm Cohort
Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Tumour size ≤ 2.5cm.
3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*
\* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.
Exclusion Criteria
2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
3. Synchronous or previous invasive or non-invasive breast cancer.
4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
5. ECOG performance status ≥3.
6. Life expectancy \<10 years.
7. Geographic inaccessibility for follow-up.
46 Years
FEMALE
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Eileen Rakovitch, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Research Institute, Sunnybrook Health Science
Tim Whelan, M.D
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre
Locations
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Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer - Abbotsford Centre
Abbotsford, British Columbia, Canada
BC Cancer - Centre for the North (Prince George)
Prince George, British Columbia, Canada
BC Cancer - Fraser Valley Centre
Surrey, 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
Royal Victoria Regional Health Centre
Barrie, Ontario, 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
Windsor Regional Cancer Centre
Windsor, 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
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec - Université Laval
Québec, 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
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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OCOG website accessed by clinical centres
Other Identifiers
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OCOG-2021-ELISA
Identifier Type: -
Identifier Source: org_study_id
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