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

NCT ID: NCT05703295

Condition: Sentinel Lymph Node Biopsy

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast cancer

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: Sentinel lymph node biopsy

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.

Criteria for eligibility:

Study pop:
All patients admitted to Assuit university hospitals more than 18 years old which candidate to sentinel lymph node biopsy during the time of the study.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: February 2023

Completion date: March 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05703295

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