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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymph Node Metastasis
• Intervention / Treatment: Diagnostic test: FROZEN SENTINEL LYMPH NODE BIOPSY

• Study Type: Observational
• Enrollment (Actual): 286

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 6300
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who were initially diagnosed with breast cancer greater than 18 years, stage T1 to T4, N0 to N1 by Section of Histopathology, Aga Khan University Hospital, Karachi from 2021 to 2022 and subsequently received neoadjuvant chemotherapy, were included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
POSITIVE CASES	Diagnostic test: FROZEN SENTINEL LYMPH NODE BIOPSY; FROZEN SENTINEL LYMPH NODE BIOPSY
NEGATIVE CASES	Diagnostic test: FROZEN SENTINEL LYMPH NODE BIOPSY; FROZEN SENTINEL LYMPH NODE BIOPSY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: ROMANA IDRESS, MBBS, FCPS, AKU

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: 2022-7303-20844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic details including age, diagnosis and results including sensitivity, specificity, and false negative rate of frozen SLNB after neoadjuvant chemotherapy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No