Active Surveillance on Papillary Thyroid Microcarcinoma
1 other identifier
observational
1,211
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
ExpectedApril 25, 2022
April 1, 2022
8.8 years
February 17, 2016
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Progression of Thyroid Papillary Microcarcinoma
rate of progression: tumor size increase of ≥3 mm in at least one dimension, tumor size increase of ≥2 mm in at least two dimensions, suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography, or pathological diagnosis of lymph node/distant metastasis
5 years
Secondary Outcomes (1)
Comparison of Progression Rate between Active Surveillance and Surgery Group
5 years
Study Arms (2)
Active surveillance
Group with active surveillance of their PTC
Surgery
Group who underwent surgery after diagnosis of PTC
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (5)
Lee JY, Kim JH, Kim YK, Lee CY, Lee EK, Moon JH, Choi HS, Yul H, Cho SW, Kim SJ, Lee KE, Park DJ, Park YJ. US Predictors of Papillary Thyroid Microcarcinoma Progression at Active Surveillance. Radiology. 2023 Oct;309(1):e230006. doi: 10.1148/radiol.230006.
PMID: 37906009DERIVEDHwang H, Choi JY, Yu HW, Moon JH, Kim JH, Lee EK, Kim YK, Lee CY, Cho SW, Chung EJ, Ryu CH, Ryu J, Yi KH, Park DJ, Lee KE, Park YJ, Kim SJ, Jung YS. Surgical Outcomes in Patients With Low-risk Papillary Thyroid Microcarcinoma From MAeSTro Study: Immediate Operation Versus Delayed Operation After Active SurveillanceA Multicenter Prospective Cohort Study. Ann Surg. 2023 Nov 1;278(5):e1087-e1095. doi: 10.1097/SLA.0000000000005841. Epub 2023 Mar 13.
PMID: 36912439DERIVEDLee 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.
PMID: 36205563DERIVEDHwangbo 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.
PMID: 35698288DERIVEDMoon 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.
PMID: 33248442DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 17, 2016
First Posted
October 19, 2016
Study Start
May 1, 2016
Primary Completion
March 1, 2025
Study Completion (Estimated)
March 1, 2030
Last Updated
April 25, 2022
Record last verified: 2022-04