CClinicalTrials.gg
Not yet recruitingNCT06782828Updated Jan 20, 2025

Accuracy of FNAC in Diagnosis of Thyroid Nodules

An observational study in Thyroid Nodule, sponsored by Assiut University. Not yet recruiting. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
10 Years to 80 Years
Sex
All
01

Study summary

Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules

Read the 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

02

Conditions studied

  • Thyroid Nodule
03

Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  1. patients with comorbidities.
  2. patients unfit for surgery
  3. patients who refused surgery.
  4. Patient with no diagnostic FNAC.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Otherobserve results of FNAC

    observe results of FNAC and compare it with results of histopathological examination to detect accuracy of FNAC in diagnosis of thyroid nodules.

05

What researchers measure

Primary outcomes

  1. Incidence of true positive results of FNAC after thyroidectomy

    Accuracy of FNAC in thyroid nodules compared to surgical specimen histopathological examination

    Time frame: 12 days

  2. Percentage of malignant thyroid nodules not observed by FNAC

    Percentage of malignant thyroid nodules that FNAC fails to detect

    Time frame: 12 days

  3. Incidence of false negative results by FNAC

    False negative that diagnosed by FNAC not malignant but proved malignancy after surgical excision

    Time frame: 12 days

  4. Percentage of total number of true results of FNAC to the total number of cases

    Accuracy of FNAC

    Time frame: 12 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Poller DN, Stelow EB, Yiangou C. Thyroid FNAC cytology: can we do it better? Cytopathology. 2008 Feb;19(1):4-10. doi: 10.1111/j.1365-2303.2007.00492.x. Epub 2007 Oct 3. PubMed 17916090 ↗
  • Bhise SV, Shaikh A, Hippargekar PM, Kothule S. A Prospective Study of Ultrasonographic and FNAC Correlation of Thyroid Swellings with Histopathology. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):1942-1948. doi: 10.1007/s12070-020-01922-w. Epub 2020 Jun 24. PubMed 36452634 ↗
  • Momin MA, Bhuiyan FU, Chakraborty S, Kar NK. FNAC and Its Utility in Solitary Thyroid Nodule and Its Correlation with Histopathological Examination. Mymensingh Med J. 2019 Apr;28(2):356-363. PubMed 31086151 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06782828
Lead sponsor
Assiut University
Responsible party
Mostafa Abed Abdulmoneim Mohammed (Principal Investigator, Assiut University) — Principal investigator
First posted
Jan 20, 2025
Start date
Mar 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 20, 2025

Study contacts

Mostafa Abed Abdulmoneim Mohammed
Contact
mostafaabed1417@gmail.com
01142799359

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion