Oncologic Safety of Sentinel Lymph Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients

Not yet recruiting

• Conditions: Sentinel Lymph Node Biopsy

• Registration Number: NCT05703295
• Lead Sponsor: Assiut University

Brief Summary

Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.

Detailed Description

Breast cancer is the most common type of cancer in females and the 3rd leading cause of cancer mortality. One of the important aspects of breast cancer management is axillary staging and the status of axillary lymph nodes is an important prognosticator that affects adjuvant treatment decisions in patients with early breast carcinoma. Sentinel lymph node biopsy (SLNB), is considered to be the standard of care for node negative breast cancer, as it can save patients from the complications of axillary lymph node dissection (ALND). These complications include lymphedema, arm stiffness, and neuralgia, all of which significantly affect the patient's quality of life and raise healthcare costs. It also allows accurate axillary staging with minimal morbidity. Oncologic outcomes in terms of disease-free survival, overall survival, and locoregional recurrence rate were similar in the SLNB alone versus the ALND group in patients with clinically node-negative axilla. In doing the SLNB, a combination of radioactive technetium-99m and blue bye technique is preferred to increase the SLN identification rate than using one technique in isolation. The rationale for performing upfront SLNB as routine for patients being treated for breast cancer should be challenged, for this our study aiming for evaluation of the role of sentinel lymph node biopsy in management of breast cancer.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-26
• Last Update Submitted: 2023-01-26
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30
• Study Start: 2023-02
• Primary Completion: 2025-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. age more than 18 years.
2. fit for surgery.
3. Patients with no previous breast surgery. .

Exclusion Criteria

1. patients less than 18 years.
2. patients unfit for surgery .
3. patients with advanced breast cancer.
4. Patients with previous breast surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients	baseline	Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.