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NCT05961280 Clinical Trial

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

Ductal Carcinoma in Situ Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05961280
Other study ID # 3-2023-0026
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 30, 2021

Study information
Verified date July 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 385
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Mastectomy with sentinel lymph node biopsy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Axillary lymph node metastasis rate Our primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery. up to 2 weeks after surgery
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