Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

NCT05912569 | Recruiting

• 1 other identifier: 2212-088-1386
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery. primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated. addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.

Conditions

DCIS

Outcome Measures

Primary Outcomes (1)

• success rate

  The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

  2 weeks later

Study Arms (1)

Delay sentinel node biopsy

EXPERIMENTAL

sinlge arm

Procedure: Delay sentinel node biopsy

Interventions

Delay sentinel node biopsy PROCEDURE

In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I

Delay sentinel node biopsy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 to 75 years old.
• Patients diagnosed with DCIS through histological examination.
• Patients undergoing mastectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 13, 2023
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)