Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05961280
• Collaborator: (none)
• Enrollment: 385
• Actual Duration (Months): 143.9

Study Details

Study Description

Brief Summary

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.

Condition or Disease	Intervention/Treatment	Phase
Ductal Carcinoma in Situ	Procedure: Mastectomy with sentinel lymph node biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 385 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Upstaging and Lymph Node Metastasis Rate in Patients With Ductal Carcinoma in Situ Who Received Mastectomy Regarding the Necessary of Sentinel Lymph Node Biopsy
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
DCIS Mastectomy Patients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy	Procedure: Mastectomy with sentinel lymph node biopsy

Outcome Measures

Primary Outcome Measures

1. Axillary lymph node metastasis rate [up to 2 weeks after surgery]

   Our primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy

2. Women underwent curative surgery for DCIS

Exclusion Criteria:

1. Patients who received breast-conserving surgery

2. Patients who had concurrent contralateral invasive breast cancer

3. Patients who were in case of ipsilateral breast tumor recurrence

4. Patients whose invasiveness was uncertain in the biopsy samples

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05961280
• Other Study ID Numbers: 3-2023-0026
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating

Study Results

No Results Posted as of Jul 27, 2023