NCT04511884

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

4.1 years

First QC Date

April 26, 2020

Last Update Submit

August 30, 2020

Conditions

Keywords

cryptogenic organizing pneumonianext-generation sequencing

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients with cryptogenic organizing pneumonia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BAI Jiu-wu

Shanghai, Please Select, 200433, China

RECRUITING

Shanghai Pulmonary Hospital, Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Cryptogenic Organizing PneumoniaIdiopathic Interstitial Pneumonias

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesIdiopathic Pulmonary FibrosisPulmonary FibrosisLung Diseases, InterstitialLung DiseasesLung Diseases, Obstructive

Central Study Contacts

Jin-fu XU, M.D

CONTACT

Jiu-wu BAI, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of respiratory and Critical Care Medicine

Study Record Dates

First Submitted

April 26, 2020

First Posted

August 13, 2020

Study Start

August 7, 2020

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations