NCT06401590

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 286 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymph Node Metastasis
• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FROZEN SENTINEL LYMPH NODE BIOPSY	FROZEN SENTINEL LYMPH NODE BIOPSY

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-03-15
• Completion: 2024-04-15
• First posted: 2024-05-06
• Last updated: 2024-05-06

Locations

1 site across 1 country: Pakistan