Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

April 19, 2025 updated by: Mohamed Hamdy Sayed, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid tumors are the most common endocrine neoplasms, with their incidence steadily rising over the past few decades, reaching approximately 8.7 cases per 100,000 people annually in Europe. The majority of thyroid tumors are benign accounting for over 90% of cases, whereas malignant thyroid tumors are relatively less common. Thyroid cancer represents 1-2% of all newly diagnosed malignancies worldwide, with papillary thyroid carcinoma (PTC) being the most prevalent (80%) followed by follicular thyroid carcinomas (FTC) (15%). Fine needle aspiration cytology (FNAC) is the primarily diagnostic tool for thyroid nodule. However, its accuracy in distinguishing between benign and malignant follicular neoplasms is limited, necessitating further histopathological evaluation. The Bethesda system classifies FNAC results into six categories, with follicular neoplasm/suspicious for follicular neoplasm (category IV) carrying a moderate risk of malignancy. Differentiating between benign and malignant follicular neoplasms requires assessing capsular and vascular invasion. Intraoperative frozen section (FS) has been used for decades to provide rapid histologic assessment guiding the extent of surgery (lobectomy Vs total thyroidectomy). However, its utility remains controversial due to variability in diagnostic accuracy and cost-effectiveness. The recent 5th edition of the WHO classification (2023) categorizes follicular-derived thyroid tumors into benign, low-risk and malignant neoplasms, further refining diagnostic criteria. This study aims to evaluate the accuracy of FNAC and FS in diagnosing follicular thyroid neoplasms, optimizing surgical decisions and reducing unnecessary total thyroidectomies in benign cases.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Universiy Hospital and Private pathology laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic Evaluation Group
Diagnostic test: Intraoperative Frozen Section

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasm
Time Frame: two weeks
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign.
two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the accuracy of fine needle aspiration cytology in diagnosis of follicular neoplasm.
Time Frame: three weeks
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Howayda I Hassan, professor, Faculty of Medicine, Assiut Universiy, Assiut, Egypt
  • Study Director: Mahmoud F Sherif, Assistant Professor, Faculty of Medicine, Assiut Universiy, Assiut, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

May 2, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2025-201196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available with the corresponding offer on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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