Diagnostic Accuracy of Fine Needle Aspiration Cytology (FNAC) Compared to TI-RADS 3 in the Evaluation of Thyroid Nodules: A Prospective Study
Thyroid Nodules
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 30 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patients with thyroid nodules classified as ACR TI-RADS 3.
- Age ≥18 years.
- Patients who provide informed consent to participate in the study.
Exclusion Criteria:
- Age \<18 years.
- Previous history of thyroid cancer.
- Previous thyroid surgery.
- Incomplete evaluation.
Treatment, groups and participation
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- Assignment
- Not applicable
- Masking
- No masking
TI-RADS 3 Thyroid Nodules Group
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) PROCEDURE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Diagnostic Performance of Fine Needle Aspiration Cytology (FNAC) Compared with Histopathological Findings in ACR TI-RADS 3 Thyroid Nodules
Time frame: through study completion, an average of 1 year
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.
Secondary measures
Distribution of FNAC Cytological Results According to the Bethesda System in ACR TI-RADS 3 Thyroid Nodules
Time frame: through study completion, an average of 1 year
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Sohag University HospitalSohag, EgyptStatus unknown
Study team and timeline
- Lead sponsor
- Sohag University
- Study start
- Apr 26, 2026 Actual
- Primary completion
- Apr 26, 2027 Estimated
- Study completion
- May 26, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Diagnostic Accuracy of Fine Needle Aspiration Cytology (FNAC) Compared to TI-RADS 3 in the Evaluation of Thyroid Nodules: A Prospective Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
