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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