跳至主要内容
临床试验/NCT04511884
NCT04511884招募中不适用

Screening Microorganism of Cryptogenic Mechanical Pneumonia Through NGS to Lung Tissue Fluid

Shanghai Pulmonary Hospital, Shanghai, China2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
The percentage of microorganisms positive for cryptogenic organizing pneumonia detected by NGS

研究概览

简要总结

The etiology of cryptogenic organizing pneumonia (COP)was not clear, but previous studies have shown that in some patients, some pathogen could be detected in bronchoalveolar lavage fluid (BALF), and may be one of the causes of COP. This study aimed to screen the pathogenic microorganisms in BALF and lung puncture fluid of the patients with COP through the next-generation sequencing to further clarify the correlation between the incidence of COP and pathogenic microorganisms.

详细描述

The cause of cryptogenic organizing pneumonia (COP) was unknown, but studies had shown that certain bacteria, viruses, or specific pathogens could be detected in bronchoalveolar lavage fluid (BALF) in some patients, and these pathogenic microorganisms may be the cause of COP. Specimens were obtained by conventional methods (sputum, blood, BALF or lung puncture fluid) for microbiological detection. Due to the influence of the quality of acquired specimens, specimen preservation and transportation which were influenced by external factors, many patients did not get good test results, which affected the diagnosis and subsequent treatment of patients. Next-generation sequencing (NGS) which could determine hundreds of thousands to millions of DNA molecules in parallel at one time, and efficiently sequence or fragment of pathogenic microorganisms. NGS had greatly improved the detection rate of pathogenic microorganisms. This study aimed to screen pathogenic microorganisms in BALF and lung puncture fluid of COP patients by NGS, and further clarify the correlation between occurrence of COP and pathogenic microorganisms.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient was older than 18 years old.
  • •The patient was organizing pneumonia (OP) through pathology.
  • •The patient was diagnosed as OP from clear cause through routine detection.
  • •Chest CT shows consolidation or ground glass

排除标准

  • •The patient has specific characteristics of connective tissue disease or autoimmune disease.
  • •The patient has a clear other cause of OP.
  • •The patient has severe systemic diseases of heart, brain, liver, kidney and so on, and cannot tolerate invasive examination
  • •The patient disapproves of invasive testing

结局指标

主要结局

The percentage of microorganisms positive for cryptogenic organizing pneumonia detected by NGS

时间窗: From 1 Dec 2019 to 1 Dec 2024

The patients with cryptogenic organizing pneumonia will be detected through electronic bronchoscopy and lung puncture. The sample will be examinated through NGS.

次要结局

未报告次要终点

研究者

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

Jin-Fu Xu

Director of respiratory and Critical Care Medicine

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (2)

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