Clinical trial · Interventional
Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules
A Prospective Randomized Study on Health-related Quality of Life of Patients With Incidental Small (<2cm) Asymptomatic Thyroid Nodules and Cost-effectiveness Analysis in Managing Small Incidental Thyroid Nodules
NCT02398721CI-TRIAL-00032778completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Ideally randomized controlled trials should be carried out to compare the cost-effectiveness between FNAC and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time. The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the Chinese population in Hong Kong.
Conditions
Conditions (1)
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 Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine Needle Aspiration Cytology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- FNAC
- description
- patients will then be randomized routine FNAC strategy
- interventionNames
- Other: Fine Needle Aspiration Cytology
- type
- NO_INTERVENTION
- label
- No FNAC
- description
- patients will be randomized to watchful observation strategy (no FNAC)
Primary outcomes (1)
- measure
- The measurement of HRQoL by SF-6D Health Survey
- timeFrame
- Two years
- description
- Health-related Quality of Life (HRQoL) preference value measured by The Chinese (HK) SF-6D Health Survey will be calculated by the Hong Kong population specific algorithm. It ranges from 0 (dead) to 1 (perfect health)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 or above * Have life expectancy of at least 6 months * Have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (USG) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on Doppler USG. For subjects with more than one nodule on USG, provided that the other nodules are not \>2.0cm or have suspicious features (see below), they will still be eligible. * Normal thyroid function (both serum thyroid-stimulating hormone (TSH) and free T4 levels within normal range) * Given consent to take part in the study Exclusion Criteria: * Have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on Doppler USG that warrant a FNAC * Nodule size \> 2.0cm * Insisting or refusing FNAC or surgical intervention despite medical reassurance * Inability to understand or communicate in Cantonese or Chinese * Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire * Too ill to carry out interview * Refusal to give consent
References
Publications (14)
- BACKGROUNDReiners C, Wegscheider K, Schicha H, Theissen P, Vaupel R, Wrbitzky R, Schumm-Draeger PM. Prevalence of thyroid disorders in the working population of Germany: ultrasonography screening in 96,278 unselected employees. Thyroid. 2004 Nov;14(11):926-32. doi: 10.1089/thy.2004.14.926. PMID 15671771
- BACKGROUNDVan den Bruel A, Francart J, Dubois C, Adam M, Vlayen J, De Schutter H, Stordeur S, Decallonne B. Regional variation in thyroid cancer incidence in Belgium is associated with variation in thyroid imaging and thyroid disease management. J Clin Endocrinol Metab. 2013 Oct;98(10):4063-71. doi: 10.1210/jc.2013-1705. Epub 2013 Aug 21. PMID 23966243
- BACKGROUNDMazzaferri EL. Management of a solitary thyroid nodule. N Engl J Med. 1993 Feb 25;328(8):553-9. doi: 10.1056/NEJM199302253280807. No abstract available. PMID 8426623
- BACKGROUNDMehanna HM, Jain A, Morton RP, Watkinson J, Shaha A. Investigating the thyroid nodule. BMJ. 2009 Mar 13;338:b733. doi: 10.1136/bmj.b733. No abstract available. PMID 19286747
- BACKGROUNDMcLeod DS, Sawka AM, Cooper DS. Controversies in primary treatment of low-risk papillary thyroid cancer. Lancet. 2013 Mar 23;381(9871):1046-57. doi: 10.1016/S0140-6736(12)62205-3. Epub 2013 Mar 22. PMID 23668555
- BACKGROUNDSosa JA, Hanna JW, Robinson KA, Lanman RB. Increases in thyroid nodule fine-needle aspirations, operations, and diagnoses of thyroid cancer in the United States. Surgery. 2013 Dec;154(6):1420-6; discussion 1426-7. doi: 10.1016/j.surg.2013.07.006. Epub 2013 Oct 2. PMID 24094448
- BACKGROUNDBonavita JA, Mayo J, Babb J, Bennett G, Oweity T, Macari M, Yee J. Pattern recognition of benign nodules at ultrasound of the thyroid: which nodules can be left alone? AJR Am J Roentgenol. 2009 Jul;193(1):207-13. doi: 10.2214/AJR.08.1820.