An interventional study of Ultrasound-Guided Fine Needle Aspiration Cytology (FNAC) in Thyroid Nodules, sponsored by Sohag University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic
Thyroid nodules are common clinical findings, and accurate differentiation between benign and malignant nodules is essential for appropriate patient management. Ultrasonography is the primary imaging modality for thyroid nodule evaluation, while the American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) provides a standardized approach for malignancy risk assessment.
Fine Needle Aspiration Cytology (FNAC) is an important diagnostic procedure for evaluating thyroid nodules, with cytological results classified according to the Bethesda System.
This prospective study aims to evaluate and compare the diagnostic accuracy of FNAC and ACR TI-RADS 3 classification in the assessment of thyroid nodules.
The study will include 30 adult patients with TI-RADS 3 thyroid nodules at Sohag University Hospital. All participants will undergo clinical examination, thyroid ultrasonography, TI-RADS classification, and ultrasound-guided FNAC. Cytological findings will be reported according to the Bethesda System. Histopathological examination of surgically excised thyroid specimens will be performed whenever available.
The diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, and negative predictive value. Statistical analysis will be performed using SPSS.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 30 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients aged 18 years or older with ACR TI-RADS 3 thyroid nodules who undergo clinical examination, thyroid ultrasonography, and ultrasound-guided Fine Needle Aspiration Cytology (FNAC). Cytological findings will be classified according to the Bethesda System. Histopathological examination of surgically excised thyroid specimens will be performed whenever available.
Procedure: Ultrasound-Guided Fine Needle Aspiration Cytology (FNAC)
Ultrasound-guided Fine Needle Aspiration Cytology (FNAC) of TI-RADS 3 thyroid nodules. The procedure will be performed to obtain cytological samples for evaluation. Cytological findings will be reported according to the Bethesda System for Reporting Thyroid Cytopathology.
Diagnostic Performance of Fine Needle Aspiration Cytology (FNAC) Compared with Histopathological Findings in ACR TI-RADS 3 Thyroid Nodules
The diagnostic performance of ultrasound-guided FNAC will be evaluated by comparing cytological findings classified according to the Bethesda System with histopathological findings in participants who undergo surgery and have available histopathological results. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy will be calculated.
Time frame: through study completion, an average of 1 year
Distribution of FNAC Cytological Results According to the Bethesda System in ACR TI-RADS 3 Thyroid Nodules
FNAC cytological findings will be classified according to the Bethesda System (Categories I-VI). The number and percentage of participants in each Bethesda category will be reported.
Time frame: through study completion, an average of 1 year
Plan to share: No — Individual participant data will not be shared with other researchers. Study data will be used for the purposes of this research and may be presented in scientific publications in an aggregated and anonymized form.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 67 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 71 studies reached it within 30 months; a quarter within 14 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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