Accuracy of FNAC in Diagnosis of Thyroid Nodules

January 17, 2025 updated by: Mostafa Abed Abdulmoneim Mohammed, Assiut University
Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Accuracy in diagnosis in any case is required, and this is beneficial to the patient and the physician, and with the development that currently exists and the trend to use less invasive techniques, accuracy of FNAC should be studied well.1.Thyroid nodules are common and the principal method of diagnosis is fine-needle aspiration cytology (FNAC).2. Can investigators depend on FNAC alone in diagnosis of thyroid nodule in the future?!3. In this study, investigators will compare the results of (FNAC) versus (Biopsy) in diagnosis of thyroid nodule in AUH , to detect the degree of accuracy of FNAC.4. FNAC is a simple, safe, cost-effective and accurate diagnostic tool for the initial screening of patients with thyroid nodules.5. Background Routine application of fine needle aspiration cytology (FNAC) has decreased unnecessary referral of thyroid nodules for surgical treatment and has also increased the cancer rates found in surgery materials. Success of thyroid FNAC depends on skilled aspiration, skilled cytological interpretation and rational analysis of cytological and clinical data. The aim of this study was to determine the diagnostic accuracy rates of thyroid FNAC results obtained in our hospital.6. The FNAC is a sensitive, specific, and accurate initial diagnostic test for the preoperative evaluation of patients with thyroid swellings in our setting as well. The correlation of cytological and histopathological diagnoses is an important quality assurance method, as it allows cytopathologists to calculate their false-positive and false negative results.7

Study Type

Observational

Enrollment (Estimated)

100

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

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

Sampling Method

Non-Probability Sample

Study Population

All patients presented to General Surgery Department with either solitary or multiple suspicious thyroid nodules during time of research.

Description

Inclusion Criteria:

  1. thyroid disease
  2. multinodular
  3. single nodule
  4. TIRAD 3 or more by US
  5. thyroid disease underwent FNAC then surgery
  6. all age groups
  7. patient fit for surgery

Exclusion Criteria:

  1. patients with comorbidities.
  2. patients unfit for surgery
  3. patients who refused surgery.
  4. Patient with no diagnostic FNAC.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of true positive results of FNAC after thyroidectomy
Time Frame: 12 days
Accuracy of FNAC in thyroid nodules compared to surgical specimen histopathological examination
12 days
Percentage of malignant thyroid nodules not observed by FNAC
Time Frame: 12 days
Percentage of malignant thyroid nodules that FNAC fails to detect
12 days
Incidence of false negative results by FNAC
Time Frame: 12 days
False negative that diagnosed by FNAC not malignant but proved malignancy after surgical excision
12 days
Percentage of total number of true results of FNAC to the total number of cases
Time Frame: 12 days
Accuracy of FNAC
12 days

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNAC in thyroid nodules

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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