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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
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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)

Condition or disease
DCIS

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 <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.

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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
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.



Primary Outcome Measures :
  1. Ipsilateral local recurrence (LR) [ Time Frame: 5 Year ]
    Defined as recurrent invasive or in situ cancer in the ipsilateral breast


Secondary Outcome Measures :
  1. Ipsilateral invasive local recurrence [ Time Frame: 5 Year ]
    defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast

  2. 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

  3. Distant disease-free survival (DDFS) [ Time Frame: 5 Year ]
    defined as time from study registration to distant recurrence

  4. 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

  5. Overall survival (OS) [ Time Frame: 5 Year ]
    defined as time from registration to death of any cause


Biospecimen Retention:   Samples With DNA
Specimens will be used to determine Oncotype DX DCIS Score and subsequent testing for future correlative studies


Information from the National Library of Medicine

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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
Study Population

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

Criteria

Inclusion Criteria:

  1. Female patient > 45 years of age with DCIS without microinvasion.
  2. Tumour size ≤ 2.5cm.
  3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.
  4. Oncotype DX DCIS score < 39 and predicted 10-year risk of LR <10%.

Exclusion Criteria:

  1. Multifocal DCIS.
  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.
  8. Inability to provide informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Brittany Speller, M.Sc 905-527-2299 ext 42611 spelleb@mcmaster.ca
Contact: Sharon Nason 905-527-2299 ext 42622 nasons@mcmaster.ca

Locations
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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   
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
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Principal Investigator: Eileen Rakovitch, M.D. Sunnybrook Research Institute, Sunnybrook Health Science
Principal Investigator: Tim Whelan, M.D Juravinski Cancer Centre
Additional Information:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Ductal Carcinoma in Situ
Breast Conserving Surgery
Oncotype DX DS
Additional relevant MeSH terms:
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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