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临床试验/NCT03320044
NCT03320044已完成不适用

Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月18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
100
试验地点
1
主要终点
The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer

研究概览

简要总结

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule,and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

详细描述

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule,then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Sign informed consent and consent to participate in this study;
  • Found small nodules in pulmonary by CT and prepare for surgery;

排除标准

  • Malignant tumor history within the past 5 years;
  • Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
  • Histology confirmed not non-small cell lung cancer
  • No matching tissue or blood samplesUnqualified blood samples

结局指标

主要结局

The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer

时间窗: 6 months

次要结局

  • The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer(6 months)
  • The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer(6 months)

研究者

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

Jun Wang

Chief,Thoracic Surgery Service

Peking University People's Hospital

研究点 (1)

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