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临床试验/NCT03830619
NCT03830619已完成不适用

Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
the CT scans of the lung for the patients

研究概览

简要总结

The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer

详细描述

Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC). The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study, exosomes from the plasma of five healthy individuals and 30 LC patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects are willing to sign the informed consent form;
  • Normal subjects have no evidence of any disease;
  • Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology

排除标准

  • People are unwilling to sign the informed consent form;
  • Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease;
  • Pregnant or lactating women;
  • Patients did not cooperate or participate in other clinical trials

结局指标

主要结局

the CT scans of the lung for the patients

时间窗: the first day subjects are enrolled the outcome will be assessed;up to three years after the completion of the study

The expression levels of serum exosome long non-coding RNA

时间窗: the first day subjects are enrolled the outcome will be assessed;up to three years after the completion of the study

the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1

时间窗: the first day subjects are enrolled the outcome will be assessed;up to three years after the completion of the study

次要结局

未报告次要终点

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Jin

professor

Wuhan Union Hospital, China

研究点 (1)

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