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

Sentinel Lymph Node Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05703295
• Other study ID #: Sentinel lymph node biopsy
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: March 2025

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Mohamed Ibrahim Mohamed
• Phone: 01002844642
• Email: mohammedibraheem22[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Sentinel Lymph Node Biopsy

Intervention

Procedure:
• Biopsy
Sentinel lymph node biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Dixon JM. Sentinel Lymph Node Biopsy in Breast Cancer Surgery. Ann Surg Oncol. 2016 Oct;23(11):3426-3428. doi: 10.1245/s10434-016-5434-6. Epub 2016 Jul 22. No abstract available. — View Citation

Qiu SQ, Zhang GJ, Jansen L, de Vries J, Schroder CP, de Vries EGE, van Dam GM. Evolution in sentinel lymph node biopsy in breast cancer. Crit Rev Oncol Hematol. 2018 Mar;123:83-94. doi: 10.1016/j.critrevonc.2017.09.010. Epub 2017 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients	Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.	baseline