Active Surveillance on Papillary Thyroid Microcarcinoma

NCT ID: NCT02938702

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2030-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Cancer Papillary Thyroid Microcarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active surveillance

Group with active surveillance of their PTC

No interventions assigned to this group

Surgery

Group who underwent surgery after diagnosis of PTC

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Joo Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 37906009 (View on PubMed)

Hwang 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.

Reference Type DERIVED
PMID: 36912439 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36205563 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35698288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33248442 (View on PubMed)

Other Identifiers

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2520160010

Identifier Type: -

Identifier Source: org_study_id

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