Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting

Completed

• Conditions: Breast Cancer; Lymph Node Metastasis
• Interventions: Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY

• Registration Number: NCT06401590
• Lead Sponsor: Aga Khan University

Brief Summary

Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2024-03-15
• Study Completion: 2024-04-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Patients greater than 18 years of age
2. All diagnosed breast carcinoma patients ranging from T1 to T4 and N0 to N1, who have received neoadjuvant chemotherapy will be included.

Exclusion Criteria

1. Poorly preserved biopsy material, insufficient to assess all the histological features.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POSITIVE CASES	FROZEN SENTINEL LYMPH NODE BIOPSY	-
NEGATIVE CASES	FROZEN SENTINEL LYMPH NODE BIOPSY	-

Primary Outcome Measures

Name	Time	Method
Number of patients with discrepant frozen and permanent biopsy results	From frozen section report to permanent section biopsy report, upto 1 week.	The results of patient's frozen biopsy report and permanent section biopsy report will be compared and sensitivity, predictive value and false negative rate of frozen section biopsy will be assessed.

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan