Status:
NOT_YET_RECRUITING
Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Seoul National University Hospital
Seoul National University Bundang Hospital
Conditions:
Thyroid Cancer
Papillary Thyroid Carcinoma
Eligibility:
All Genders
19-79 years
Phase:
NA
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; in...
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. Dur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT06971965
Start Date
June 2 2025
End Date
December 31 2032
Last Update
May 14 2025
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