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

NCT ID: NCT04511884

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-07

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Interstitial Pneumonias Cryptogenic Organizing Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Next-generation sequencing

The patient who may be diagnosed with cryptogenic organizing pneumonia will be detected through next-generation sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Jin-Fu Xu

Director of respiratory and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BAI Jiu-wu

Shanghai, Please Select, China

Site Status RECRUITING

Shanghai Pulmonary Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin-fu XU, M.D

Role: CONTACT

8621-65115006

Jiu-wu BAI, M.D

Role: CONTACT

8621-65115006

Facility Contacts

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Role: primary

Kai xing Ai

Role: primary

+86-021-65115006

Other Identifiers

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2020040695

Identifier Type: -

Identifier Source: org_study_id

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