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

NCT02398721 | Completed DMC

• 1 other identifier: UW 14-500
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

FNAC; Small Incidental Thyroid Nodules

Outcome Measures

Primary Outcomes (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)

  Two years

Secondary Outcomes (1)

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

  Two years

Study Arms (2)

FNAC

OTHER

patients will then be randomized routine FNAC strategy

Other: Fine Needle Aspiration Cytology

No FNAC

NO INTERVENTION

patients will be randomized to watchful observation strategy (no FNAC)

Interventions

Fine Needle Aspiration Cytology OTHER

Also known as: FNAC

FNAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (14)

• 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.

  PMID: 15671771 BACKGROUND

• 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.

  PMID: 23966243 BACKGROUND

• 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.

  PMID: 8426623 BACKGROUND

• 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.

  PMID: 19286747 BACKGROUND

• 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.

  PMID: 23668555 BACKGROUND

• 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.

  PMID: 24094448 BACKGROUND

• 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.

  PMID: 19542415 BACKGROUND

• 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.

  PMID: 20020290 BACKGROUND

• 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.

  PMID: 23564944 BACKGROUND

• 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.

  PMID: 21228935 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32307641 DERIVED

• 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.

  PMID: 31741168 DERIVED

• 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.

  PMID: 28224296 DERIVED

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: March 31, 2015
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

HK (1)