Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorNational Cancer Center, Korea
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
Hyperthyroidism
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.
Trial design
Treatments tested in this trial
- Levothyroxin
Treatment groups
578 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
National Cancer Center, Korea
Lead sponsor
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Source ClinicalTrials.gov