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

August 30, 2020 updated by: Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jin-fu XU, M.D
  • Phone Number: 8621-65115006
  • Email: jfxucn@163.com

Study Contact Backup

  • Name: Jiu-wu BAI, M.D
  • Phone Number: 8621-65115006
  • Email: yv59@163.com

Study Locations

  • China
    • Please Select
      • Shanghai, Please Select, China, 200433
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Pulmonary Hospital, Tongji University
        • Contact:
          • Kai xing Ai
          • Phone Number: +86-021-65115006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients with cryptogenic organizing pneumonia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of microorganisms positive for cryptogenic organizing pneumonia detected by NGS
Time Frame: 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.
From 1 Dec 2019 to 1 Dec 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2020

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020040695

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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