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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
578
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.
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.
Time frame: at 3,5years after enrollment
Disease free survival
As the time interval from enrollment to either disease progression or all-cause mortality, whichever occurs first.
Time frame: at 3,5years after enrollment
Disease specific survival
As the time from the date of enrollment to disease-specific mortality.
Time frame: at 3,5years after enrollment
Overall Survival
As the time from the date of enrollment to death.
Time frame: 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.
Time frame: 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.
Time frame: at 3,5years after enrollment
Safety evaluation
Incidence and grade of adverse events.
Time frame: at 3,5years after enrollment
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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.
Time frame: 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).
Time frame: 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.
Time frame: at 3,5years after enrollment
Test interval for efficient diagnosis of recurrence
To analyze the duration until recurrence and the interval between examinations.
Time frame: at 3,5years after enrollment