Clinical trial NCT02938702: Active Surveillance on Papillary Thyroid Microcarcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Thyroid Cancer
Papillary Thyroid Microcarcinoma
Keywords: Active surveillance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 1211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient aged older than 18 years with papillary thyroid microcarcinoma less than 1 cm in length, who did not meet the exclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and Borame Medical Center.

Brief summary: The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.


Eligibility criteria: Inclusion Criteria:

* who agreed to the agreement form
* who is older than 18 years old
* who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI
* whose thyroid cancer is smaller than 1 cm length

Exclusion Criteria:

* who cannot routinely follow-up according to the study schedule
* who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV.
* who have hyperthyroidism which needs treatment

Primary outcomes:
measure: Rate of Progression of Thyroid Papillary Microcarcinoma
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of Progression Rate between Active Surveillance and Surgery Group
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee EK, Moon JH, Hwangbo Y, Ryu CH, Cho SW, Choi JY, Chung EJ, Jeong WJ, Jung YS, Ryu J, Kim SJ, Kim MJ, Kim YK, Lee CY, Lee JY, Yu HW, Hah JH, Lee KE, Lee YJ, Park SK, Park DJ, Kim JH, Park YJ. Progression of Low-Risk Papillary Thyroid Microcarcinoma During Active Surveillance: Interim Analysis of a Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma in Korea. Thyroid. 2022 Nov;32(11):1328-1336. doi: 10.1089/thy.2021.0614.
citation: Hwangbo Y, Choi JY, Lee EK, Ryu CH, Cho SW, Chung EJ, Hah JH, Jeong WJ, Park SK, Jung YS, Kim JH, Kim MJ, Kim SJ, Kim YK, Lee CY, Lee JY, Lee YJ, Yu HW, Park DJ, Ryu J, Park YJ, Lee KE, Moon JH. A Cross-Sectional Survey of Patient Treatment Choice in a Multicenter Prospective Cohort Study on Active Surveillance of Papillary Thyroid Microcarcinoma (MAeSTro). Thyroid. 2022 Jul;32(7):772-780. doi: 10.1089/thy.2021.0619.
citation: Moon JH, Ryu CH, Cho SW, Choi JY, Chung EJ, Hah JH, Hwangbo Y, Jeong WJ, Jung YS, Kim JH, Kim MJ, Kim SJ, Kim YK, Lee CY, Lee EK, Lee JY, Lee KE, Lee YJ, Lee Y, Yu HW, Park DJ, Ryu J, Park YJ. Effect of Initial Treatment Choice on 2-year Quality of Life in Patients with Low-risk Papillary Thyroid Microcarcinoma. J Clin Endocrinol Metab. 2021 Mar 8;106(3):724-735. doi: 10.1210/clinem/dgaa889.