Thyroid CancerNCT02938702
Active Surveillance on Papillary Thyroid Microcarcinoma
An observational study of Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- How many people
- 1,211 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- Keywords
- Active surveillance
- Medical subject headings
- Thyroid Neoplasms, Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active surveillance | Group with active surveillance of their PTC | |
| Surgery | Group who underwent surgery after diagnosis of PTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Comparison of Progression Rate between Active Surveillance and Surgery Group
Which group had higher progression rate; progression defined as whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2025 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938702
- Sponsor's protocol ID
- 2520160010
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37906009Hwang 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.
PubMed 36912439Lee 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.
PubMed 36205563Hwangbo 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.
PubMed 35698288Moon 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.
PubMed 33248442
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance on Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT02938702
- Acronym / sponsor ID
- 2520160010
- Conditions
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- Keywords
- Active surveillance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,211 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | – | –Group with active surveillance of their PTC |
| Surgery | – | –Group who underwent surgery after diagnosis of PTC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Progression of Thyroid Papillary Microcarcinoma
Time frame: 5 years
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
1 secondary outcome
Comparison of Progression Rate between Active Surveillance and Surgery Group
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 37906009Lee 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.
- Derived from this study: PubMed 36912439Hwang 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.
- Derived from this study: PubMed 36205563Lee 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.
- Derived from this study: PubMed 35698288Hwangbo 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.
- Derived from this study: PubMed 33248442Moon 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.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
RecruitingPhase 2
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Thyroid Cancer
Active, not recruitingObservational study
Natural History Study of Children and Adults With Medullary Thyroid Cancer
Medullary Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Apr 2022. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Progression of Thyroid Papillary Microcarcinoma (time frame: 5 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 NCT02938702, which also lists 5 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 25 Apr 2022.