Clinical Trials Logo
  1. Home
  2. Ductal Carcinoma In Situ
  3. NCT05961280
  4. Details
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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02889458 - Hong Kong Breast Cancer Study
Completed NCT00757302 - Intraoperative Gamma Camera for Breast Cancer Surgery Phase 3
Active, not recruiting NCT03216421 - Intraoperative Radiation Therapy (IORT) in DCIS N/A
Completed NCT03775213 - Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS) N/A
Active, not recruiting NCT00605982 - Breast MRI as a Preoperative Tool for DCIS N/A
Enrolling by invitation NCT04365114 - Patient Outcomes From Second Film-readers and Test Threshold Relaxation in Breast Screening
Completed NCT04248179 - The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery. Phase 4
Withdrawn NCT05032079 - Subzero and Scorpion Trial N/A
Recruiting NCT05218044 - Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ N/A
Active, not recruiting NCT01644669 - Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System® N/A
Recruiting NCT06133647 - Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
Completed NCT01815476 - The Prone Breast Radiation Therapy Trial N/A
Not yet recruiting NCT06033092 - Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion Phase 2
Terminated NCT02137252 - Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer Phase 2
Terminated NCT01060345 - A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ Phase 2
Recruiting NCT00669747 - Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS) Phase 2
Completed NCT00742222 - Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer Phase 4
Active, not recruiting NCT02909426 - The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness
Recruiting NCT02928978 - Ruxolitinib for Premalignant Breast Disease Phase 2
Completed NCT03375892 - The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure N/A