Clinical trial Recruiting at 1 site Interventional Ages 20 to 75

Delayed sentinel node biopsy for patients with DCIS undergoing mastectomy

Official title: Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ

Run by Seoul National University Hospital · NCT05912569 · Data updated 2026-11-12

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

Study typeInterventional
Ages20 Years to 75 Years
SexAll
Enrollment84 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedJune 13, 2023
Main results expectedApril 28, 2025
Study endsApril 28, 2025
Registry record updatedJanuary 31, 2025
Trial IDNCT05912569 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 20 to 75 years diagnosed with DCIS who are scheduled for total mastectomy.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in the field.

Who can join: the full rules

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 it's running

  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.