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Thyroid NodulesNCT02398721

Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules

A study testing Fine Needle Aspiration Cytology in people with Thyroid Nodules, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Nodules
What is being tested?
Fine Needle Aspiration Cytology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteHong Kong
Study dates
31 Mar 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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
Thyroid Nodules
Being tested
Fine Needle Aspiration Cytology
Keywords
FNAC, Small Incidental Thyroid Nodules
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fine Needle Aspiration CytologyOther

    Also called FNAC

Study groups in NCT02398721
Study groupRoleWhat they receive
FNACOtherpatients will then be randomized routine FNAC strategy
Receives: Other: Fine Needle Aspiration Cytology
No FNACNo interventionpatients will be randomized to watchful observation strategy (no FNAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The measurement of HRQoL by SF-6D Health Survey

    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)

    Measured: Two years

Secondary outcomes (1)

  1. The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma

    The effectiveness of managing small incidental thyroid nodules is quantified by quality-adjusted life years (QALYs), which will be calculated as the product of average duration of each stage (including no illness) and the SF-6D preference value for that particular health state.

    The direct health care costs of different strategies in managing small incidental thyroid nodules will be estimated using the costs published by the Government Gazette and previous literatures.

    HRQOL measured by the Chinese (Hong Kong) Short Form-12 (SF-12) Health Survey version 2 and FACT-G will be evaluated to identify these major problem of life.

    Health service utilizations of patients with thyroid neoplasm will be surveyed.

    Treatment effect on the HRQOL of patients with thyroid carcinoma will be explored.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study start31 Mar 2015
  3. Primary completionJul 2017
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02398721
Sponsor's protocol ID
UW 14-500
Status last verified
May 2018
First submitted
20 Mar 2015
Last updated
4 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Reiners 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.

    PubMed 15671771

  • Van 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.

    PubMed 23966243

  • Mazzaferri 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.

    PubMed 8426623

  • Mehanna 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.

    PubMed 19286747

  • McLeod 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.

    PubMed 23668555

  • Sosa 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.

    PubMed 24094448

  • Bonavita 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.

    PubMed 19542415

  • Ito Y, Miyauchi A, Inoue H, Fukushima M, Kihara M, Higashiyama T, Tomoda C, Takamura Y, Kobayashi K, Miya A. An observational trial for papillary thyroid microcarcinoma in Japanese patients. World J Surg. 2010 Jan;34(1):28-35. doi: 10.1007/s00268-009-0303-0.

    PubMed 20020290

  • Pacini F. Management of papillary thyroid microcarcinoma: primum non nocere! J Clin Endocrinol Metab. 2013 Apr;98(4):1391-3. doi: 10.1210/jc.2013-1634. No abstract available.

    PubMed 23564944

  • Moon WJ, Baek JH, Jung SL, Kim DW, Kim EK, Kim JY, Kwak JY, Lee JH, Lee JH, Lee YH, Na DG, Park JS, Park SW; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ultrasonography and the ultrasound-based management of thyroid nodules: consensus statement and recommendations. Korean J Radiol. 2011 Jan-Feb;12(1):1-14. doi: 10.3348/kjr.2011.12.1.1. Epub 2011 Jan 3.

    PubMed 21228935

  • American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated

  • Wong CKH, Liu X, Lang BHH. Cost-effectiveness of fine-needle aspiration cytology (FNAC) and watchful observation for incidental thyroid nodules. J Endocrinol Invest. 2020 Nov;43(11):1645-1654. doi: 10.1007/s40618-020-01254-0. Epub 2020 Apr 19.

    PubMed 32307641

  • Wong CKH, Lang BHH. A randomized trial comparing health-related quality-of-life and utility measures between routine fine-needle aspiration cytology (FNAC) and surveillance alone in patients with thyroid incidentaloma measuring 1-2 cm. Endocrine. 2020 Feb;67(2):397-405. doi: 10.1007/s12020-019-02129-y. Epub 2019 Nov 18.

    PubMed 31741168

  • Wong CKH, Lang BHH, Yu HMS, Lam CLK. EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation. Patient. 2017 Aug;10(4):447-454. doi: 10.1007/s40271-017-0220-5.

    PubMed 28224296

Questions about this trial

What is this clinical trial studying?

A study testing Fine Needle Aspiration Cytology in people with Thyroid Nodules, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The measurement of HRQoL by SF-6D Health Survey (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02398721, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.

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