Clinical trial NCT05069194: Study on the Etiology, Risk Factors and Pathogenesis of COPD Based on Clinical Bioinformatics
Official title: Study on the Etiology, Risk Factors and Pathogenesis ofCOPD Based on Clinical Bioinformatics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: The Second Affiliated Hospital of Fujian Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Xibei Hospital
name: Henan Provincial People's Hospital
name: Shenzhen University
name: Shantou University Medical College
name: Shanghai Minhang Central Hospital
name: Shanghai Fengxian District Central Hospital
name: Sun Med IT(ShangHai) Co. Ltd
First posted: 2021-10-06
Enrollment: 13000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from Shanghai City, Wenzhou City, Quanzhou City, Zhengzhou City and Xi'an City.

Brief summary: The risk factors and causes of chronic obstructive pulmonary disease（COPD）are not clear, so the prevalence of COPD is high and the prevention effect is not good. Because the pathogenesis of COPD is not completely elucidated, the diagnosis and classification of COPD are inaccurate which resulting in poor efficacy of treatment. Therefore, it is of great scientific and clinical significance to find out the risk factors and causes of COPD, to clarify its pathogenesis, to put forward the prevention and early intervention measures of COPD, to warn the occurrence of COPD, to predict the deterioration of the disease, to reduce the occurrence of COPD and to slow down the progress of COPD.

The project establishes a cohort of COPD people，high-risk group and the healthy group. The project studys the risk factors, etiology and pathogenesis of COPD. The project studys the interaction between genetic factors and environmental factors on COPD and its effect on pathogenesis, progression and outcome of COPD.

Detailed description: The project establishes the data base and specimen bank for COPD.Then clinical bioinformatics technology is uesd to analyze the clinical information and epidemiological information. In the same time, Omics methods are used to study COPD-related genes and biomarkers . Finally, a multi-factor risk factor model for the occurrence and development of COPD is established by combining clinical information, epidemiological information and biomics results.

Eligibility criteria: Inclusion Criteria:

① Inclusion criteria for patients with COPD:

* Over 18 years of age.
* FEV1 / FVC\< 70% was the diagnostic criterion for COPD after inhaling bronchodilators.

  ② Inclusion criteria for high-risk subjects:
* Over 18 years of age.
* Physical examination and routine laboratory tests were normal.
* Chest CT to exclude other pulmonary diseases.
* Lung function does not meet the diagnostic criteria for COPD.
* having one of the following risk factors: A. Smoking: current smokers, smoking index (number of years of smoking × number of cigarettes per day)≥ L.

B. Biofuel exposure: Subjects frequently use charcoal, wood, and animal dung for home heating and cooking Or crops are defined as having a history of exposure to biofuels. C. Dust and chemical exposure: mining, quarrying, casting, grain dust, paint, chemicals and others (including non-return) In the above categories of self-reported) occupational dust or gas smoke exposure for more than 1 year.

③ Inclusion criteria of healthy control subjects:

* Over 18 years of age.
* Physical examination and routine laboratory tests were normal.
* Chest CT to exclude other pulmonary diseases.
* Lung function does not meet the diagnostic criteria for COPD.
* No risk factors (including smoking, biofuel exposure, dust or chemical exposure).

Exclusion Criteria:

* History of other chronic lung diseases, such as bronchiectasis, pulmonary interstitial fibrosis, etc.
* History of acute lung disease within 3 months.
* History of malignant tumor.
* Pregnant and lactating women.

Primary outcomes:
measure: Risk factors and pathogenesis of of COPD
timeFrame: From date of participation in project until December 31, 2022
Secondary outcomes:
measure: Clinical bioinformatics database for COPD
timeFrame: From date of participation in project until December 31, 2022
measure: Biological library of COPD
timeFrame: From date of participation in project until December 31, 2022
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The first affiliated hospital of wenzhou medical university
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: ChengShui Chen
role: STUDY_CHAIR
References: