Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 578
- 主要终点
- Rate of Disease progression
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
low TSH group
0.3 ≤ target TSH <2.0mIU/L
干预措施: Levothyroxin (Drug)
high TSH group
2.0 ≤ target TSH <8.0mIU/L
干预措施: Levothyroxin (Drug)
结局指标
主要结局
Rate of Disease progression
时间窗: at 3,5years after enrollment
The rate of disease progression will be assessed as the proportion (%) of patients with biopsy-confirmed recurrence, based on suspicious findings identified through thyroid (neck) ultrasound performed at 6- to 12-month intervals.
次要结局
- Disease free survival(at 3,5years after enrollment)
- Disease specific survival(at 3,5years after enrollment)
- Overall Survival(at 3,5years after enrollment)
- Target-TSH-level achievement rate(at 3,5years after enrollment)
- Test interval for efficient diagnosis of recurrence(at 3,5years after enrollment)
- Incidence of complications(at 3,5years after enrollment)
- Safety evaluation(at 3,5years after enrollment)
- Risk Factors for Thyroid Cancer Recurrence(at 3,5years after enrollment)
- Predictors of Treatment-Related Complications Based on Thyroid Hormone Levels(at 3,5years after enrollment)
- Predictors of TSH levels and proper thyroid hormone dosage(at 3,5years after enrollment)