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临床试验/NCT04477798
NCT04477798Unknown不适用

Protein Classifier for Thyroid Indeterminate Nodules: a Multi-center Prospective Clinical Study

Luo Dingcun1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
1
主要终点
protein classifier

研究概览

简要总结

In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with aged 18 to 70 years old;
  • Patients with thyroid nodules who have not been treated with drugs;
  • Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
  • Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
  • Patients voluntarily participate in the study after informed consent.

排除标准

  • Patients without operation;
  • Patients with insufficient FNA sample size (judged by the laboratory).

结局指标

主要结局

protein classifier

时间窗: immediately after the procedure

classify thyroid indeterminate nodules as Benign or Malignant

次要结局

未报告次要终点

研究者

发起方
Luo Dingcun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luo Dingcun

vice president of hospital

Zhejiang University

研究点 (1)

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