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临床试验/NCT03294005
NCT03294005已完成不适用

Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 1,949 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,949
试验地点
1
主要终点
Accuracy with (TP+TN)/(TP+TN+FP+TN)

研究概览

简要总结

Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the hypothyroidism with the popular name "the big neck". After many experts study and evaluation, goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the thyroid gland was widespread on the Taiwan island. This situation was a particular victim in living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid gland disease really popular than other areas. Recently literature reported that the cancer rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer prevalence probably has 10% in the nodular goiter.

The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to have special training cytological pathology doctor. Therefore, if we can have simple fast screening tool and can make up this insufficiency, then we can achieved the fast diagnosis, rapid processing, the promotion diagnosis and treatment quality and promotes the survival percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early diagnosis & management this disease.

This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey and analysis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

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

入选标准

  • Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December in CMUH.
  • Patients had thyroid sonography within one year before thyroidectomy.
  • All data at least was interpreted by 3 endocrinologists under the blind method.

排除标准

  • Patients with nodular goiter hadn't thyroidectomy.
  • Patients hadn't thyroid sonography.
  • All data was interpreted by endocrinologists under the blind method, but interpretation results were inconsistent.

结局指标

主要结局

Accuracy with (TP+TN)/(TP+TN+FP+TN)

时间窗: Jun 2018

次要结局

  • Sensitivity with TP/(TP+FN)(Jun 2018)
  • Specificity with TN/(TN+FP)(Jun 2018)
  • Negative predictive value (NPV) with TN/(TN+FN)(Jun 2018)
  • Positive predictive value (PPV) with TP/(TP+FP)(Jun 2018)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chwen-Tzuei Chang

Consultant

China Medical University Hospital

研究点 (1)

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