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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401590
• Other study ID #: 2022-7303-20844
• Status: Completed
• Start date: March 15, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2024
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Lymph Node Metastasis
• Lymphatic Metastasis

Intervention

Diagnostic Test:
• FROZEN SENTINEL LYMPH NODE BIOPSY
FROZEN SENTINEL LYMPH NODE BIOPSY

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with discrepant frozen and permanent biopsy results	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.	From frozen section report to permanent section biopsy report, upto 1 week.