Clinical trial NCT06971965: Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
Official title: Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Papillary Thyroid Carcinoma
Keywords: Active Surveillance
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
First posted: 2025-05-14
Enrollment: 578
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Primary outcomes:
measure: Rate of Disease progression
timeFrame: at 3,5years after enrollment
Secondary outcomes:
measure: Disease free survival
timeFrame: at 3,5years after enrollment
measure: Disease specific survival
timeFrame: at 3,5years after enrollment
measure: Overall Survival
timeFrame: at 3,5years after enrollment
measure: Target-TSH-level achievement rate
timeFrame: at 3,5years after enrollment
measure: Incidence of complications
timeFrame: at 3,5years after enrollment
measure: Safety evaluation
timeFrame: at 3,5years after enrollment
measure: Risk Factors for Thyroid Cancer Recurrence
timeFrame: at 3,5years after enrollment
measure: Predictors of Treatment-Related Complications Based on Thyroid Hormone Levels
timeFrame: at 3,5years after enrollment
measure: Predictors of TSH levels and proper thyroid hormone dosage
timeFrame: at 3,5years after enrollment
measure: Test interval for efficient diagnosis of recurrence
timeFrame: at 3,5years after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Center
name: Eun Kyung Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Young Joo Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Minjoo Kim
role: PRINCIPAL_INVESTIGATOR
References: