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

Idiopathic Interstitial Pneumonias Clinical Trial

— COPandNGS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511884
• Other study ID #: 2020040695
• Status: Recruiting
• Start date: August 7, 2020
• Est. completion date: December 2024

Study information

• Verified date: August 2020
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-fu XU, M.D
• Phone: 8621-65115006
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryptogenic Organizing Pneumonia
• Idiopathic Interstitial Pneumonias
• Lung Diseases, Interstitial
• Pneumonia

Intervention

Diagnostic Test:
• Next-generation sequencing
The patient who may be diagnosed with cryptogenic organizing pneumonia will be detected through next-generation sequencing.

Locations

Country	Name	City	State
China	BAI Jiu-wu	Shanghai	Please Select
China	Shanghai Pulmonary Hospital, Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of microorganisms positive for cryptogenic organizing pneumonia detected by NGS	The patients with cryptogenic organizing pneumonia will be detected through electronic bronchoscopy and lung puncture. The sample will be examinated through NGS.	From 1 Dec 2019 to 1 Dec 2024