Thyroid CancerMAeSTro-TSHNCT06971965
Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
A study testing Levothyroxin in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by National Cancer Center, Korea.
Trial summary
This study is a multicenter randomized controlled trial conducted in Korea. A parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low TSH group; intervention) is different from the wIthout thyroid stimulating hormone (TSH) suppression therapy group(high TSH group… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Carcinoma
- What is being tested?
- Levothyroxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2025to 31 Dec 2032
- Phase
- Interventional
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
- Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
- Non-pregnant women of childbearing potential (confirmed by medical history taking)
Who cannot join
- Hyperthyroidism
- If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:
- Myocardial infarction or cerebrovascular accident within the last three months.
- Diseases with limited life expectancy or potentially impairing the patient's ability to comply with at least five years of treatment or follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a multicenter randomized controlled trial conducted in Korea. A parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low TSH group; intervention) is different from the wIthout thyroid stimulating hormone (TSH) suppression therapy group(high TSH group; control).
Read the detailed description
Patients diagnosed with papillary thyroid cancer who wanted Active surveillance and meet the inclusion / exclusion criteria will be randomized 1: 1 into two groups: the high TSH and low TSH group. During the study period, thyroid hormone supplementary doses will be determined according to the dose-adjustment protocol established for each target TSH range.
- Conditions
- Thyroid Cancer, Papillary Thyroid Carcinoma
- Being tested
- Levothyroxin
- Keywords
- Active Surveillance
- 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.
LevothyroxinDrug
During the five-year study intervention period, thyroid hormone (oral administration) supplementary doses are determined according to a dose-adjustment protocol established for the group's target TSH range.
| Study group | Role | What they receive |
|---|---|---|
| low TSH group | Experimental | 0.3 ≤ target TSH <2.0mIU/L Receives: Drug: Levothyroxin |
| high TSH group | Experimental | 2.0 ≤ target TSH <8.0mIU/L Receives: Drug: Levothyroxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Disease progression
The rate of disease progression will be assessed as the proportion (%) of patients with biopsy-confirmed recurrence, based on suspicious findings identified through thyroid (neck) ultrasound performed at 6- to 12-month intervals.
Measured: at 3,5years after enrollment
Secondary outcomes (10)
Disease free survival
As the time interval from enrollment to either disease progression or all-cause mortality, whichever occurs first.
Measured: at 3,5years after enrollment
Disease specific survival
As the time from the date of enrollment to disease-specific mortality.
Measured: at 3,5years after enrollment
Overall Survival
As the time from the date of enrollment to death.
Measured: at 3,5years after enrollment
Target-TSH-level achievement rate
Comparison of between the low-TSH and high-TSH groups at each follow-up visit regarding the presence or absence of thyroid hormone use and its dosage, considering body weight and medication adherence, in order to achieve the target TSH concentration.
Measured: at 3,5years after enrollment
Incidence of complications
Comparison of the incidence of complications at each follow-up visit between the low-TSH and high-TSH groups.
Measured: at 3,5years after enrollment
Safety evaluation
Incidence and grade of adverse events.
Measured: at 3,5years after enrollment
Risk Factors for Thyroid Cancer Recurrence
The study will assess the relationship between thyroid hormone levels (TSH, free T4, total T3 or free T3) and potential risk factors for recurrence, including:
- Demographic factors: sex, age, smoking status, BMI
- Pathologic features: tumor stage, size, extrathyroidal extension
- Genetic mutations: BRAF, TERT promoter mutations
The analysis will identify factors, adjusted for thyroid hormone levels, significantly associated with recurrence risk. Statistical methods such as Generalized Estimating Equations (GEE), Interval Censored Survival Analysis, and Cox-proportional hazards regression will be used for evaluation.
Measured: at 3,5years after enrollment
Predictors of Treatment-Related Complications Based on Thyroid Hormone Levels
The study will assess the relationship between thyroid hormone levels (TSH, free T4, total T3 or free T3) and risk factors for treatment-related complications (e.g., tachycardia, reduced bone mineral density). Risk factors include:
- Demographic factors: sex, age, smoking, BMI, weight, blood pressure, concurrent medications, menopausal status, diabetes, asthma/COPD, rheumatic diseases
- Cholesterol levels: Total cholesterol, LDL, HDL
- ECG and Bone Mineral Density (BMD)
The analysis will evaluate the association between these factors and treatment-related complications, adjusting for thyroid hormone levels. Incidence rates of complications at follow-up will be compared using Chi-square, Fisher's exact test, or Generalized Estimating Equations (GEE).
Measured: at 3,5years after enrollment
Predictors of TSH levels and proper thyroid hormone dosage
This study will identify factors that predict changes in thyroid hormone levels (TSH, free T4, total T3, or free T3) and predict the required thyroid medication dosing. The factors under include:
- Demographic Factors: Sex, age, comorbidities, smoking status, body mass index (BMI), weight, and current medications
- Thyroid Function: Pre-existing thyroid disorders, and the presence of thyroiditis
The analysis will evaluate the association between these factors and changes in thyroid hormone levels, as well as predict the necessary adjustments in thyroid hormone dosing, using multiple regression analysis.
Measured: at 3,5years after enrollment
Test interval for efficient diagnosis of recurrence
To analyze the duration until recurrence and the interval between examinations.
Measured: at 3,5years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start2 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eun Kyung Lee, Principal investigator, National Cancer CenterYoung Joo Park, Principal investigator, Seoul National University HospitalMinjoo Kim, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971965
- Sponsor's protocol ID
- 2025-0173
- Acronym
- MAeSTro-TSH
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
- ClinicalTrials.gov ID
- NCT06971965
- Acronym / sponsor ID
- MAeSTro-TSH / 2025-0173
- Conditions
- Thyroid Cancer, Papillary Thyroid Carcinoma
- Keywords
- Active Surveillance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 14 May 2025 (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 study is a multicenter randomized controlled trial conducted in Korea. A parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low TSH group; intervention) is different from the wIthout thyroid stimulating hormone (TSH) suppression therapy group(high TSH group; control).
Detailed description
Patients diagnosed with papillary thyroid cancer who wanted Active surveillance and meet the inclusion / exclusion criteria will be randomized 1: 1 into two groups: the high TSH and low TSH group. During the study period, thyroid hormone supplementary doses will be determined according to the dose-adjustment protocol established for each target TSH range.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low TSH group | Experimental | Drug: Levothyroxin0.3 ≤ target TSH <2.0mIU/L |
| high TSH group | Experimental | Drug: Levothyroxin2.0 ≤ target TSH <8.0mIU/L |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
- Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
- Non-pregnant women of childbearing potential (confirmed by medical history taking)
Key exclusion criteria (4 listed)
- Hyperthyroidism
- If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxinDuring the five-year study intervention period, thyroid hormone (oral administration) supplementary doses are determined according to a dose-adjustment protocol established for the group's target TSH range. | Drug | high TSH group, low TSH group |
Primary outcome
Rate of Disease progression
Time frame: at 3,5years after enrollment
The rate of disease progression will be assessed as the proportion (%) of patients with biopsy-confirmed recurrence, based on suspicious findings identified through thyroid (neck) ultrasound performed at 6- to 12-month intervals.
10 secondary outcomes
Disease free survival
Time frame: at 3,5years after enrollment
Disease specific survival
Time frame: at 3,5years after enrollment
Overall Survival
Time frame: at 3,5years after enrollment
Target-TSH-level achievement rate
Time frame: at 3,5years after enrollment
Incidence of complications
Time frame: at 3,5years after enrollment
Safety evaluation
Time frame: at 3,5years after enrollment
Risk Factors for Thyroid Cancer Recurrence
Time frame: at 3,5years after enrollment
Predictors of Treatment-Related Complications Based on Thyroid Hormone Levels
Time frame: at 3,5years after enrollment
Predictors of TSH levels and proper thyroid hormone dosage
Time frame: at 3,5years after enrollment
Test interval for efficient diagnosis of recurrence
Time frame: at 3,5years after enrollment
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Eun Kyung Lee principal investigator
National Cancer Center
Young Joo Park principal investigator
Seoul National University Hospital
Minjoo Kim principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxin in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by National Cancer Center, 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eun Kyung Lee (+82-31-920-1743, eklee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Disease progression (time frame: at 3,5years 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 14 May 2025.