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Completed

NCT Number: NCT05961280

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy
  • Women underwent curative surgery for DCIS

Exclusion criteria

  • Patients who received breast-conserving surgery
  • Patients who had concurrent contralateral invasive breast cancer
  • Patients who were in case of ipsilateral breast tumor recurrence
  • Patients whose invasiveness was uncertain in the biopsy samples

Treatment and study plan

Mastectomy with sentinel lymph node biopsy

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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