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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05703295

Collaborator

(none)

Enrollment

24.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sentinel Lymph Node Biopsy	Procedure: Biopsy

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

patients less than 18 years.
patients unfit for surgery .
patients with advanced breast cancer.
Patients with previous breast surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mohamed Ibraheem Mohamed, Resident, Assiut University

ClinicalTrials.gov Identifier:

NCT05703295

Other Study ID Numbers:

Sentinel lymph node biopsy

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Ibraheem Mohamed, Resident, Assiut University

Breast cancer

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jan 30, 2023