Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797299
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2021-03-10
Brief Title:
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ DCIS
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELISA
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
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 Groups OCOG web-based registration system A two-step registrationenrollment process will be implemented
Data related to the patient demographics surgery details tumour characteristics and ECOG performance will be collected The patients 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
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 Groups OCOG web-based registration system A two-step registrationenrollment process will be implemented
Data related to the patient demographics surgery details tumour characteristics and ECOG performance will be collected The patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None