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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2032-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Thyroid Cancer Papillary Thyroid Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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low TSH group

0.3 ≤ target TSH \<2.0mIU/L

Group Type EXPERIMENTAL

Levothyroxin

Intervention Type 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.

high TSH group

2.0 ≤ target TSH \<8.0mIU/L

Group Type EXPERIMENTAL

Levothyroxin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No