An interventional study of Levothyroxin in Thyroid Cancer and Papillary Thyroid Carcinoma, sponsored by National Cancer Center, Korea. Not yet recruiting. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Health services research
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.
186 studies on the registry are indexed under Thyroid Cancer, Papillary; 51 are open to participants now.
This study's planned enrollment of 578 is above the median of 41 across 114 interventional studies indexed under Thyroid Cancer, Papillary.
Browse Thyroid Cancer, Papillary studies →National Cancer Center, Korea is the lead sponsor of 204 studies on the registry; 36 are open to participants now.
Compared within Thyroid Cancer, Papillary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.3 ≤ target TSH \<2.0mIU/L
Drug: Levothyroxin
2.0 ≤ target TSH \<8.0mIU/L
Drug: Levothyroxin
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Dec 2027, 30 months later.
Of 26 interventional studies with no phase under Thyroid Cancer, Papillary, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 71. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thyroxine
National Cancer Center, Korea →