Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07928284
By invitationNCT07928284ClinicalTrials.gov record

Diagnostic Accuracy of Fine Needle Aspiration Cytology (FNAC) Compared to TI-RADS 3 in the Evaluation of Thyroid Nodules: A Prospective Study

Thyroid Nodules

THE QUICK READ

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.
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

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.

Prepare your questions

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

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