Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS) (ELISA)
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ClinicalTrials.gov Identifier: NCT04797299 |
Recruitment Status :
Recruiting
First Posted : March 15, 2021
Last Update Posted : February 2, 2023
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Condition or disease |
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DCIS |
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 <39 and a predicted 10-year risk of local recurrence <10%, these patients 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 every 6 months for the first 2 years and then yearly up to 10 years. Bilateral mammograms will be performed 6 months after BCS and then annually. The study data will be verified by source documentation.
Study Type : | Observational |
Estimated Enrollment : | 526 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | October 20, 2022 |
Estimated Primary Completion Date : | March 31, 2035 |
Estimated Study Completion Date : | July 31, 2035 |
Group/Cohort |
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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.
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- Ipsilateral local recurrence (LR) [ Time Frame: 5 Year ]Defined as recurrent invasive or in situ cancer in the ipsilateral breast
- Ipsilateral invasive local recurrence [ Time Frame: 5 Year ]defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast
- Breast cancer recurrence-free interval (RFI) [ Time Frame: 5 Year ]defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer
- Distant disease-free survival (DDFS) [ Time Frame: 5 Year ]defined as time from study registration to distant recurrence
- Disease-free survival (DFS) [ Time Frame: 5 Year ]defined as time from registration to time of LR (DCIS or invasive), regional and distant recurrence, contralateral breast cancer, new primary (non-breast) and death from any cause
- Overall survival (OS) [ Time Frame: 5 Year ]defined as time from registration to death of any cause
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 46 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Prospective cohort study conducted in Canada in women with a low risk DCIS following breast conserving surgery who are candidates for radiation.
Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment
Inclusion Criteria:
- Female patient > 45 years of age with DCIS without microinvasion.
- Tumour size ≤ 2.5cm.
- Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.
- Oncotype DX DCIS score < 39 and predicted 10-year risk of LR <10%.
Exclusion Criteria:
- Multifocal DCIS.
- History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
- Synchronous or previous invasive or non-invasive breast cancer.
- Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
- ECOG performance status ≥3.
- Life expectancy <10 years.
- Geographic inaccessibility for follow-up.
- Inability to provide informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04797299
Contact: Brittany Speller, M.Sc | 905-527-2299 ext 42611 | spelleb@mcmaster.ca | |
Contact: Sharon Nason | 905-527-2299 ext 42622 | nasons@mcmaster.ca |
Canada, British Columbia | |
BC Cancer - Victoria | Recruiting |
Victoria, British Columbia, Canada, V8R 6V5 | |
Contact: Negin Shahid, M.D. 250-519-5570 negin.shahid@bccancer.bc.ca | |
Contact: Emily White 250-519-5500 ext 693531 emily.white@bccancer.bc.ca | |
Canada, Ontario | |
Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Mira Goldberg, M.D 905-387-9495 goldbergm@hhsc.ca | |
Contact: Stacey Correia 905-387-9495 correias@hhsc.ca | |
London Regional Cancer Program | Not yet recruiting |
London, Ontario, Canada, N6A 4L6 | |
Contact: Francisco Perera, M.D. 519-685-8650 francisco.perera@lhsc.on.ca | |
Contact: Rebecca Petrie 519-685-8618 rebecca.petrie@lhsc.on.ca | |
Regional Cancer Care, Thunder Bay Regional Health Sciences Centre | Recruiting |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Contact: Margaret Anthes, M.D. 807-684-7566 anthesm@tbh.net | |
Contact: Lori Moon 807-684-7226 lori-ann.moon@tbh.net | |
Sunnybrook Health Science Centre -Odette Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Eileen Rakovitch, M.D. 416-480-4806 eileen.rakovitch@sunnybrook.ca | |
Contact: Clarissa Chau 416-480-6100 clarissa.chau@sunnybrook.ca | |
University Health Network - Princess Margaret Cancer Centre | Not yet recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Anne Koch, M.D. 416-946-4662 anne.koch@rmp.uhn.on.ca | |
Canada, Quebec | |
Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre) | Recruiting |
Greenfield Park, Quebec, Canada, J4V 2H1 | |
Contact: Nancy El-Bared, M.D. 450-466-5000 nancy.el-bared.med@ssss.gouv.qc.ca | |
Contact: Caroline Hivon 450-466-5000 caroline.hivon.cisssmc16@ssss.gouv.qc.ca | |
Jewish General Hospital | Recruiting |
Montréal, Quebec, Canada, H3T 1E2 | |
Contact: Thierry Muanza, MD 514-340-8222 thierry.muanza.med@ssss.gouv.qc.ca | |
Contact: Vitania D'Alonzo, BSc 514-340-8222 Vitania.Dalonzo.ccomtl@ssss.gouv.qc.ca | |
Centre intégré de cancérologie du CHU de Québec - Université Laval | Recruiting |
Québec City, Quebec, Canada, G1J 1Z4 | |
Contact: Valérie Théberge, M.D. 418-691-5264 valerie.theberge.med@ssss.gouv.qc.ca | |
Contact: Josée Allard 418-691-5264 Josee.Allard@chudequebec.ca | |
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières | Recruiting |
Trois-Rivières, Quebec, Canada, G8Z 3R9 | |
Contact: Francois Vincent, M.D. 819-371-5002 francois_vincent@ssss.gouv.qc.ca | |
Contact: Marie-Eve Caron 819-697-3333 ext 63238 marie-eve_caron_chrtr@ssss.gouv.qc.ca |
Principal Investigator: | Eileen Rakovitch, M.D. | Sunnybrook Research Institute, Sunnybrook Health Science | |
Principal Investigator: | Tim Whelan, M.D | Juravinski Cancer Centre |
Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT04797299 |
Other Study ID Numbers: |
OCOG-2021-ELISA |
First Posted: | March 15, 2021 Key Record Dates |
Last Update Posted: | February 2, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ductal Carcinoma in Situ Breast Conserving Surgery Oncotype DX DS |
Carcinoma Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Breast Carcinoma In Situ |