Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS) (ELISA)

March 21, 2024 updated by: Ontario Clinical Oncology Group (OCOG)

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

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)

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre
        • Principal Investigator:
          • Jeffrey Q Cao, MD
        • Contact:
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Prince George, British Columbia, Canada, V2M 7E9
        • Recruiting
        • BC Cancer - Centre for the North (Prince George)
        • Principal Investigator:
          • Robert Olson, MD
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer - Vancouver Centre
        • Contact:
        • Principal Investigator:
          • Iwa Kong, MD
      • Victoria, British Columbia, Canada, V8R 6V5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • QE II HSC - Nova Scotia Cancer Centre
        • Principal Investigator:
          • Robert Rutledge, MD
        • Contact:
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Recruiting
        • Cape Breton Cancer Centre
        • Contact:
        • Principal Investigator:
          • Kwamena Beecham, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Principal Investigator:
          • Tim Whelan, MD
        • Contact:
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Regional Cancer Program
        • Principal Investigator:
          • Francisco Perera, MD
        • Contact:
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Recruiting
        • Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
        • Principal Investigator:
          • Margaret Anthes, MD
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Science Centre -Odette Cancer Centre
        • Principal Investigator:
          • Eileen Rakovitch, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network - Princess Margaret Cancer Centre
        • Principal Investigator:
          • Ezra Hahn, MD
        • Contact:
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Christine Lambert, MD
      • Montréal, Quebec, Canada, H3T 1E2
        • Withdrawn
        • Jewish General Hospital
      • Québec City, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec - Université Laval
        • Contact:
        • Principal Investigator:
          • Valérie Théberge, MD
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
        • Contact:
        • Principal Investigator:
          • Francois Vincent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

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

Description

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.*

    * 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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral local recurrence (LR)
Time Frame: 5 Year
Defined as recurrent invasive or in situ cancer in the ipsilateral breast
5 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral invasive local recurrence
Time Frame: 5 Year
defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast
5 Year
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
5 Year
Distant disease-free survival (DDFS)
Time Frame: 5 Year
defined as time from study registration to distant recurrence
5 Year
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 Year
Overall survival (OS)
Time Frame: 5 Year
defined as time from registration to death of any cause
5 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Investigators

  • Principal Investigator: Eileen Rakovitch, M.D., Sunnybrook Research Institute, Sunnybrook Health Science
  • Principal Investigator: Tim Whelan, M.D, Juravinski Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2022

Primary Completion (Estimated)

March 31, 2035

Study Completion (Estimated)

May 31, 2035

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2021-ELISA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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