Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

NCT06947629 | Not Yet Recruiting DMC

• 1 other identifier: 04-2025-201196
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy). The main questions, it aims to answer are: The follicular neoplasm is benign or malignent? how far is FNAC valid and accurate? Researchers will compare the results of frozen section and paraffin embedded sections to evaluate the validity and accuracy of FNAC.

Conditions

Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

Outcome Measures

Primary Outcomes (1)

• Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasm

  Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign.

  two weeks

Secondary Outcomes (1)

• Assessment of the accuracy of fine needle aspiration cytology in diagnosis of follicular neoplasm.

  three weeks

Study Arms (1)

Diagnostic Evaluation Group

EXPERIMENTAL

Diagnostic Test: Intraoperative Frozen Section

Interventions

Intraoperative Frozen Section DIAGNOSTIC_TEST

Intraoperative Frozen Section analysis which will include the following steps: \- The specimen will undergo both gross and microscopic examination: 1. Gross examination: Evaluation of nodular features including, multiplicity, size, outlines, color and consistency. 2. Microscopic examination: Assessment of capsular pattern, capsular invasion, thickness of capsule, vascular invasion and number of invaded vessels and the presence or absence of papillary structures.

Diagnostic Evaluation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases presented with a thyroid nodule, diagnosed as "follicular neoplasm" (Bethesda category IV) by fine needle aspiration cytology, and underwent hemi-thyroidectomy.

You may not qualify if:

• Cases with thyroid nodule and diagnosed by fine needle aspiration cytology as non-neoplastic lesions, suspicious for malignancy or as malignant.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Universiy Hospital and Private pathology laboratory

Asyut, Egypt

Location

Study Officials

• Howayda I Hassan, professor

  Faculty of Medicine, Assiut Universiy, Assiut, Egypt

  STUDY CHAIR

• Mahmoud F Sherif, Assistant Professor

  Faculty of Medicine, Assiut Universiy, Assiut, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohamed H Sayed, MBBCh

CONTACT

+201004419027; MohamedHamdy2020@med.nvu.edu.eg

Mahmoud F Sherif, Assistant professor

CONTACT

01002763939; M.farouk.pathology@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Pathology Department In New Valley University

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 27, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 2, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)