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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low TSH group | Experimental | 0.3 ≤ target TSH <2.0mIU/L |
|
| high TSH group | Experimental | 2.0 ≤ target TSH <8.0mIU/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 3,5years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | As the time interval from enrollment to either disease progression or all-cause mortality, whichever occurs first. | at 3,5years after enrollment |
| Disease specific survival |
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Inclusion Criteria:
Exclusion Criteria:
Hyperthyroidism
If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Kyung Lee | Contact | +82-31-920-1743 | eklee@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Eun Kyung Lee | National Cancer Center | Principal Investigator |
| Young Joo Park | Seoul National University Hospital | Principal Investigator |
| Minjoo Kim |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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As the time from the date of enrollment to disease-specific mortality.
| at 3,5years after enrollment |
| Overall Survival | As the time from the date of enrollment to death. | 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. | 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. | at 3,5years after enrollment |
| Safety evaluation | Incidence and grade of adverse events. | 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:
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. | 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:
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). | 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:
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. | at 3,5years after enrollment |
| Test interval for efficient diagnosis of recurrence | To analyze the duration until recurrence and the interval between examinations. | at 3,5years after enrollment |
| Seoul National University Bundang Hospital |
| Principal Investigator |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |