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

NCT06401590 | Completed

• 1 other identifier: 2022-7303-20844
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymph Node Metastasis; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

POSITIVE CASES

Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY

NEGATIVE CASES

Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY

Interventions

FROZEN SENTINEL LYMPH NODE BIOPSY DIAGNOSTIC_TEST

FROZEN SENTINEL LYMPH NODE BIOPSY

NEGATIVE CASES; POSITIVE CASES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 6300, Pakistan

Location

MeSH Terms

Conditions

Lymphatic Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ROMANA IDRESS, MBBS, FCPS

  AKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: March 15, 2022
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)