A Multicenter randomized controlled study for assessing the usefulness of suppressing Thyroid Stimulating Hormone Target Levels after thyroid lobectomy in low to intermediate risk thyroid cancer patients.
- Conditions
- Neoplasms
- Registration Number
- KCT0004989
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2986
• Patients with histological confirmation of papillary thyroid cancer*
* Papillary thyroid cancer (TNM(tumor, node, and metastasis) stage is evaluated according to the 8th edition of AJCC(American Joint Committee on Cancer)/UICC(The Union for International Cancer Control) TNM(tumor, node, and metastasis) staging system (2017))
-Maximum tumor diameter = 4 cm
-Extrathyroidal extension: No invasion of adjacent organs(nerves, vascular, trachea, etc)
-Node stage: Clinical N0, N1a
• Patients who will receive thyroid lobectomy, or who received thyroid lobectomy within previous 3 weeks
• Non-pregnant women of childbearing potential (confirmed by medical history taking)
• Ages 19 to 80 (less than 80)
• If there are nodules in the opposite lobe: Thyroid nodules are evaluated by ultrasound (based on K-TIRADS(Korean Thyroid Imaging Reporting and Data System)). Bethesda classification criteria 1-3 if the fine needle aspiration test is indicated
• The following patients in the postoperative findings
-pT4, pN1b or M1
- PTC with Aggressive histological features
: diffuse sclerosing variant
-Other types of thyroid cancer (follicular, poorly differentiated, anaplastic, or medullary thyroid cancer)
• Completion thyroidectomy is required
• Residual disease present(R1/ R2 resection)
• No proper evaluation of nodules located in the contralateral lobe,
or Bethesda classification criteria 4-6 in the result of fine needle aspiration test
• Hyperthyroidism
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Disease free survival;Disease specific survival;Target-TSH-level achievement rate;The incidence of cardiovascular and metabolic complications (cardiovascular disease, Arrhythmia, hypercholesterolemia, fatty liver, etc.);The incidence of musculoskeletal complications (fracture, bone density reduction, sarcopenia);The incidence of psychiatric complications (lower quality of life, affective disorder, etc.);Cost analysis (related medical expenses, loss of productivity);predictors of recurrence;predictors of cardiovascular complications;predictors of musculoskeletal complications;predictors of psychiatric complications;predictors of TSH levels and proper thyroid hormone dosage;Genetic susceptibility (Consider secondary analysis);Test interval for efficient diagnosis of recurrence