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Not yet recruiting NCT06971965

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

No phase Interventional Thyroid Cancer Papillary Thyroid Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levothyroxin.
Who it may be relevant to
Registry conditions: Thyroid Cancer, Papillary Thyroid Carcinoma. Basic parameters: 19 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Rate of Disease progression [Time frame: at 3,5years after enrollment]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06971965 · 2025-0173

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗