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Screening Microorganism of Cryptogenic Mechanical Pneumonia Through Next Generation Sequencing to Lung Tissue Fluid

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The patient was older than 18 years old. 2. The patient was organizing pneumonia (OP) through pathology. 3. The patient was diagnosed as OP from clear cause through routine detection. 4. Chest CT shows consolidation or ground glass.

Exclusion Criteria:

1. The patient has specific characteristics of connective tissue disease or autoimmune disease. 2. The patient has a clear other cause of OP. 3. The patient has severe systemic diseases of heart, brain, liver, kidney and so on, and cannot tolerate invasive examination. 4. The patient disapproves of invasive testing

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04511884
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Pulmonary Hospital, Shanghai, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cryptogenic Organizing Pneumonia, Idiopathic Interstitial Pneumonias

Additional Details

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.

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