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

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ClinicalTrials.gov Identifier: NCT05961280
Recruitment Status : Completed
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital

Study Description
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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
Ductal Carcinoma in Situ Procedure: Mastectomy with sentinel lymph node biopsy

Study Design
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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 : January 1, 2010
Actual Primary Completion Date : December 30, 2021
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Mastectomy

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Axillary lymph node metastasis rate [ Time Frame: 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
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.
Criteria

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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT05961280    
Other Study ID Numbers: 3-2023-0026
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ