Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06971965

Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillary Thyroid Carcinoma Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

levothyroxin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Disease free survival

    Time frame: at 3,5years after enrollment

    As the time interval from enrollment to either disease progression or all-cause mortality, whichever occurs first.

  2. Disease specific survival

    Time frame: at 3,5years after enrollment

    As the time from the date of enrollment to disease-specific mortality.

  3. Overall Survival

    Time frame: at 3,5years after enrollment

    As the time from the date of enrollment to death.

  4. Target-TSH-level achievement rate

    Time frame: at 3,5years after enrollment

    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.

  5. Incidence of complications

    Time frame: at 3,5years after enrollment

    Comparison of the incidence of complications at each follow-up visit between the low-TSH and high-TSH groups.

  6. Safety evaluation

    Time frame: at 3,5years after enrollment

    Incidence and grade of adverse events.

  7. Risk Factors for Thyroid Cancer Recurrence

    Time frame: at 3,5years after enrollment

    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.

  8. Predictors of Treatment-Related Complications Based on Thyroid Hormone Levels

    Time frame: at 3,5years after enrollment

    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).

  9. Predictors of TSH levels and proper thyroid hormone dosage

    Time frame: at 3,5years after enrollment

    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.

  10. Test interval for efficient diagnosis of recurrence

    Time frame: at 3,5years after enrollment

    To analyze the duration until recurrence and the interval between examinations.

Study contacts

Contact information is provided by the study sponsor or research team.

Eun Kyung Lee

CONTACT

[email protected]

+82-31-920-1743

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Registry information

Acronym: MAeSTro-TSH

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.