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

NCT ID: NCT05703295

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-03-31

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.

Conditions

Sentinel Lymph Node Biopsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Biopsy

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ibraheem Mohamed

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Ibrahim Mohamed

Role: CONTACT

mohammedibraheem22@yahoo.com

01002844642 ext. 01114024156

Mostafa Thabet Ahmed, Professor

Role: CONTACT

mostafaharera@yahoo.com

01002798144

References

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.

Reference Type: BACKGROUND

PMID: 27448117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29482783 (View on PubMed)

Other Identifiers

Sentinel lymph node biopsy

Identifier Type: -

Identifier Source: org_study_id