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临床试验/NCT02868476
NCT02868476Unknown不适用

Long Period Observation of Biochemical Survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases

National Taiwan University Hospital0 个研究点目标入组 532 人开始时间: 2016年8月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
532
主要终点
Long Period Observation of Biochemical survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases

研究概览

简要总结

Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future.The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.

详细描述

Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Thyroid ultrasonography could differentiate benign or malignant nodular lesion, together with fine needle aspiration cytology and surgical pathology. Thyrotropin (TSH, thyroid stimulating hormone) is the pivotal investigation in laboratory diagnosis to define subclinical thyroid diseases. An elevated TSH with normal free thyroxine and triiodothyronine levels in serum is defined to be subclinical hypothyroidism, and a subnormal TSH with normal thyroid hormone concentrations to be subclinical hyperthyroidism. Generally, the prevalence of subclinical hypothyroidism and hyperthyroidism were reported as 4% -10% & 1%-2% in general population, respectively. Although subclinical thyroid disease is prevalent, there is still no consensus for screening clinical and subclinical thyroid disease, including hyperthyroidism, hypothyroidism, nodular goiter and thyroid cancer. Under consideration of age, gender or familial history of autoimmune thyroid disease. However, screening for thyroid dysfunction should be considered in some high risk patients, including 1) elderly; 2) history of atrial fibrillation; 3) previous thyroid disease history; 4) other confirmed autoimmune diseases; 5) neck exposure of radiation (for example, nasopharyngeal cancer, post-radiation); 6) family history of probable autoimmune thyroid disease, and 7) pregnant state with prior thyroid disease history. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. Therapeutic options will be anti-thyroid medications and/or radioactive iodine, and thyroidectomy could be considered with larger goiters for hyperthyroidism. For clinical and subclinical hypothyroidism, the therapeutic consideration should be aimed on reduction of progression to overt hypothyroidism, improving heart function, correction of dyslipidemia, and relieving senescence depressive mood. Thyroid ultrasonography will help us to keep long term observation of thyroid structural change. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future. We hope to check the relationship between various thyroid diseases and biochemical survey/ultrasonography. The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-80 years old
  • Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years.

排除标准

  • 未提供

结局指标

主要结局

Long Period Observation of Biochemical survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases

时间窗: 5 years

The study was designed as prospective pattern, and the investigators enrolled new patients with hyperthyroidism/hypothyroidism/nodular goiter/thyroid cancer with long period follow-up, then record thyroid change of thyroid function after treatment of anti-thyroid drugs or thyroid hormone replacement; the clinical outcome of nodular goiter with serial fine needle aspiration cytology and the correlation with thyroid ultrasonography, with the volume/echogenicity/vascularity of nodular goiters. Try to find the correlation of outcome (including how long will the anti-thyroid drugs be stopped without thyroid ablation, the natural course of benign nodular goiters without operation; or thyroid cancer recurrence, thyroid cancer, lymph nodes metastasis or distant metastasis, with surgery/radioactive iodine ablation/target therapy) with regular follow-up in outpatient department via time-dependent manner at least 5 years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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