This trial is active, not recruiting.

Condition thyroid nodules
Treatment fine needle aspiration cytology
Sponsor The University of Hong Kong
Start date May 2015
End date July 2017
Trial size 314 participants
Trial identifier NCT02398721, UW 14-500


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
patients will then be randomized routine FNAC strategy
fine needle aspiration cytology FNAC
(No Intervention)
patients will be randomized to watchful observation strategy (no FNAC)

Primary Outcomes

The measurement of HRQoL by SF-6D Health Survey
time frame: Two years

Secondary Outcomes

The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma
time frame: Two years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The University of Hong Kong.