Delayed sentinel node biopsy for patients with DCIS undergoing mastectomy
Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
NA · Seoul National University Hospital · NCT05912569
This study is testing a new way to handle lymph node surgery for women with DCIS who are having a mastectomy, by marking the lymph node to remove later only if invasive cancer is found, to avoid unnecessary surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05912569 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel approach to sentinel lymph node biopsy in patients diagnosed with ductal carcinoma in situ (DCIS) who are undergoing total mastectomy. Instead of removing the sentinel lymph node during the initial surgery, it is marked for identification and only excised later if invasive cancer is confirmed through histological examination. The primary endpoint is to evaluate the success rate of identifying the marked sentinel lymph node in cases where invasive cancer is detected. This method aims to minimize unnecessary procedures while ensuring accurate staging of cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 20 to 75 years diagnosed with DCIS who are scheduled for total mastectomy.
Not a fit: Patients with suspicious invasive lesions or those who have previously undergone axillary lymph node surgery on the same side will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more targeted and less invasive surgical interventions for patients with DCIS.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 20 to 75 years old. * Patients diagnosed with DCIS through histological examination. * Patients undergoing mastectomy Exclusion Criteria: * In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions. * In cases where imaging tests or physical examinations suggest possible lymph node metastasis. * In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure. * Pregnant patients.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: DCIS