Study on the Etiology, Risk Factors and Pathogenesis of COPD Based on Clinical Bioinformatics

NCT ID: NCT05069194

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 13000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-10
• Study Completion Date: 2022-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD

Patients with chronic obstructive pulmonary disease

No interventions assigned to this group

High Risk

People who do not suffer from COPD, but have high risk factor for COPD.

No interventions assigned to this group

Health

People who do not suffer from COPD and do not have a high risk factor for COPD either.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Xibei Hospital

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Shenzhen University

OTHER

Sponsor Role: collaborator

Shantou University Medical College

OTHER

Sponsor Role: collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role: collaborator

Shanghai Fengxian District Central Hospital

OTHER

Sponsor Role: collaborator

Sun Med IT(ShangHai) Co. Ltd

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ChengShui Chen

Role: STUDY_CHAIR

First Affiliated Hospital of Wenzhou Medical University

Locations

The first affiliated hospital of wenzhou medical university

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yang

Role: CONTACT

taiyang2630@163.com

0086-13777780071

Facility Contacts

chengshui Chen

Role: primary

Other Identifiers

2016YFC1304000

Identifier Type: -

Identifier Source: org_study_id