Cryptogenic Organizing PneumoniaCOPandNGSNCT04511884
Screening Microorganism of Cryptogenic Mechanical Pneumonia Through Next Generation Sequencing to Lung Tissue Fluid
An observational study of Cryptogenic Organizing Pneumonia and Idiopathic Interstitial Pneumonias, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cryptogenic Organizing Pneumonia, Idiopathic Interstitial Pneumonias
- What is being tested?
- Next-generation sequencing
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 7 Aug 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The patients with cryptogenic organizing pneumonia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
BAI Jiu-wu
Shanghai, Please Select, 200433
yv59@163.com
- Recruiting
Shanghai Pulmonary Hospital, Tongji University
Shanghai, Shanghai Municipality, 200000
Kai xing Ai, +86-021-65115006
About this study
Official title: 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.
Read the 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.
- Being tested
- Next-generation sequencing
- Keywords
- cryptogenic organizing pneumonia, next-generation sequencing
- Medical subject headings
- Cryptogenic Organizing Pneumonia, Idiopathic Interstitial Pneumonias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation sequencingDiagnostic test
The patient who may be diagnosed with cryptogenic organizing pneumonia will be detected through next-generation sequencing.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 Dec 2019 to 1 Dec 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start7 Aug 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic Organizing PneumoniaStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511884
- Sponsor's protocol ID
- 2020040695
- Acronym
- COPandNGS
- Status last verified
- Aug 2020
- First submitted
- 26 Apr 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Microorganism of Cryptogenic Mechanical Pneumonia Through NGS to Lung Tissue Fluid
- ClinicalTrials.gov ID
- NCT04511884
- Acronym / sponsor ID
- COPandNGS / 2020040695
- Keywords
- cryptogenic organizing pneumonia, next-generation sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients with cryptogenic organizing pneumonia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next-generation sequencingThe patient who may be diagnosed with cryptogenic organizing pneumonia will be detected through next-generation sequencing. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Organizing Pneumonia and Idiopathic Interstitial Pneumonias, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-fu XU, M.D (8621-65115006, jfxucn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of microorganisms positive for cryptogenic organizing pneumonia detected by NGS (time frame: From 1 Dec 2019 to 1 Dec 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.