Thyroid CancerMAeSTro-EXPNCT06261190
Active Surveillance for Low-risk Papillary Thyroid Carcinoma
An observational study of Thyroid Cancer and Papillary Thyroid Carcinoma, run by National Cancer Center, Korea at 4 sites in South Korea.
Trial summary
This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Carcinoma
- How many people
- 499 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 6 Mar 2024to 31 Dec 2032
- 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: Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center.
Who may be able to join
- subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
- subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.
Who cannot join
- subjects who are unable or unwilling to attend regular follow-ups..
- subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites
National Cancer Center
Goyang-si
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul
SMC-SNU Boramae Medical Center
Seoul
About this study
Official title: Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTro-EXP)
This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.
Read the detailed description
The primary objective of this study is to evaluate the natural course of low-risk papillary thyroid cancer, specifically the progression rates of tumor size increase and the occurrence of local or distant metastasis. Ultimately, it is expected that establishing new criteria for active surveillance of low-risk papillary thyroid cancer in Korean patients will lead to a reduction in unnecessary surgical treatments, improving quality of life and decreasing national healthcare costs.
- Conditions
- Thyroid Cancer, Papillary Thyroid Carcinoma
- Keywords
- Active Surveillance, Immediate surgery
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary
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 Papillary Thyroid Cancer | |
| Immediate surgery | Group who underwent surgery after diagnosis Papillary Thyroid Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease progression between the active surveillance group and the immediate surgery group
Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.
Measured: At 5years, 10years after enrollment
Secondary outcomes (6)
Risk factors for disease progression in the active surveillance group
To evaluate the risk factors for progression to thyroid cancer based on demographic factors, serial ultrasound findings, blood markers, and molecular pathological characteristics at each follow-up visit.
Measured: At 5years, 10years after enrollment
Rate of conversion to surgery without disease progression in the active surveillance group
To estimate the proportion of patients in the active surveillance group who undergo surgery without clinical evidence of progression to thyroid cancer, evaluated at each follow-up visit.
Measured: At 5years, 10years after enrollment
Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group
The outcome will be measured as the proportion (%) of patients in each group who experience disease progression at each follow-up visit.
Disease progression is defined as meeting any of the following criteria:
- an increase in tumor size of ≥3 mm in maximum diameter, or ≥2 mm in two perpendicular diameters;
- a cytopathological diagnosis of a new thyroid cancer lesion;
- a cytopathological diagnosis of cervical lymph node metastasis;
- clinical or radiological suspicion of distant metastasis.
Measured: At 5years, 10years after enrollment
Factors influencing treatment decision-making
To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment.
Measured: At 5years, 10years after enrollment
Decision Conflict Scale Score
The level of confidence in decision-making will be assessed at each follow-up visit using the Decision Conflict Scale. This questionnaire evaluates the level of agreement with statements related to treatment plan decisions on a scale from 0 (strongly disagree) to 5 (strongly agree), in 1-point increments. Higher scores indicate greater confidence and certainty in the decision-making process.
Measured: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Shared Decision-Making Satisfaction Score
To assess patient satisfaction with the shared decision-making process with healthcare providers. Satisfaction is measured using a questionnaire rated on a scale from 0 (very dissatisfied) to 10 (very satisfied), with 1-point increments. Higher scores indicate greater satisfaction with the collaborative decision-making process.
Measured: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start6 Mar 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- 499 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261190
- Sponsor's protocol ID
- H-2308-182-1463
- Acronym
- MAeSTro-EXP
- Status last verified
- May 2025
- First submitted
- 25 Jan 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTro-EXP)
- ClinicalTrials.gov ID
- NCT06261190
- Acronym / sponsor ID
- MAeSTro-EXP / H-2308-182-1463
- Conditions
- Thyroid Cancer, Papillary Thyroid Carcinoma
- Keywords
- Active Surveillance, Immediate surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 499 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Seoul National University Hospital
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 15 Feb 2024 (actual)
- 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.
This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.
Detailed description
The primary objective of this study is to evaluate the natural course of low-risk papillary thyroid cancer, specifically the progression rates of tumor size increase and the occurrence of local or distant metastasis. Ultimately, it is expected that establishing new criteria for active surveillance of low-risk papillary thyroid cancer in Korean patients will lead to a reduction in unnecessary surgical treatments, improving quality of life and decreasing national healthcare costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | – | –Group with active surveillance of their Papillary Thyroid Cancer |
| Immediate surgery | – | –Group who underwent surgery after diagnosis Papillary Thyroid Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center.
Key inclusion criteria (2 listed)
- subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
- subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.
Key exclusion criteria (2 listed)
- subjects who are unable or unwilling to attend regular follow-ups..
- subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.
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 disease progression between the active surveillance group and the immediate surgery group
Time frame: At 5years, 10years after enrollment
Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.
6 secondary outcomes
Risk factors for disease progression in the active surveillance group
Time frame: At 5years, 10years after enrollment
Rate of conversion to surgery without disease progression in the active surveillance group
Time frame: At 5years, 10years after enrollment
Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group
Time frame: At 5years, 10years after enrollment
Factors influencing treatment decision-making
Time frame: At 5years, 10years after enrollment
Decision Conflict Scale Score
Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Shared Decision-Making Satisfaction Score
Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
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 11 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Carcinoma, run by National Cancer Center, Korea at 4 sites 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 disease progression between the active surveillance group and the immediate surgery group (time frame: At 5years, 10years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.