NCT04797299 Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
| NCT ID | NCT04797299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ontario Clinical Oncology Group (OCOG) |
| Condition | DCIS |
| Study Type | OBSERVATIONAL |
| Enrollment | 526 participants |
| Start Date | 2022-11-23 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 526 participants in total. It began in 2022-11-23 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility 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.\* \* 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.
Contact & Investigator
Eileen Rakovitch, M.D.
PRINCIPAL INVESTIGATOR
Sunnybrook Research Institute, Sunnybrook Health Science
Frequently Asked Questions
Who can join the NCT04797299 clinical trial?
This trial is open to female participants only, aged 46 Years or older, studying DCIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04797299 currently recruiting?
Yes, NCT04797299 is actively recruiting participants. Contact the research team at spelleb@mcmaster.ca for enrollment information.
Where is the NCT04797299 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Abbotsford British Columbia, Canada, Prince George, Canada and 11 additional locations.
Who is sponsoring the NCT04797299 clinical trial?
NCT04797299 is sponsored by Ontario Clinical Oncology Group (OCOG). The principal investigator is Eileen Rakovitch, M.D. at Sunnybrook Research Institute, Sunnybrook Health Science. The trial plans to enroll 526 participants.