Clinical trial · Interventional
The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology?
Selective Ultrasound Guided Cytology Using EU-TIRADS Versus Non-selective Ultrasound Guided Cytology for Diagnosing Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using EU-TIRADS versus non-selective ultrasound guided cytology. Primary outcome is frequency of suspicious cytology (Bethesda III-VI) which is expected to be higher in the selective group compared to the non-selective group. Secondary outcome is the frequency of malignancy which is expected to be equal in both groups. However, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-selective cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Selective cytology according to EU-TIRADS
- description
- All thyroid nodules are evaluated according to EU-TIRADS and cytology is performed according to EU-TIRADS criteria.
- type
- ACTIVE_COMPARATOR
- label
- Non-selective cytology
- description
- All thyroid nodules are evaluated according to EU-TIRADS and cytology is performed on all nodules \>1 cm. Cytology will also be performed on EU-TIRADS 5-nodules measuring between 0.5 and 1 cm.
- interventionNames
- Diagnostic Test: Non-selective cytology
Primary outcomes (1)
- measure
- Frequency of suspicious cytology (Bethesda III-VI) in each arm.
- timeFrame
- Through study completion, up to 18 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred to ultrasonography of the thyroid due to goiter symtoms or positive findings on FDG-PET Exclusion Criteria: * Patients previously examined with ultrasonography of the thyroid * Patients who have previously undergone thyroid surgery
References
Publications (3)
- BACKGROUNDRuss G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8. PMID 29167761
- BACKGROUNDCibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500. PMID 29091573
- DERIVEDDahlberg J, Carlqvist J, Ortoft A, Hammarstedt L, Aula E, Hellstrom M, Elias E, Muth A. A randomized controlled trial comparing non-selective versus selective TIRADS-based cytology in thyroid cancer diagnostics. Br J Surg. 2026 Jul 2;113(7):znag076. doi: 10.1093/bjs/znag076. PMID 42322189