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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069194
• Other study ID #: 2016YFC1304000
• Status: Recruiting
• Start date: December 10, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Li Yang
• Phone: 0086-13777780071
• Email: taiyang2630[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

? Inclusion criteria for patients with COPD:

• Over 18 years of age.

• FEV1 / FVC< 70% was the diagnostic criterion for COPD after inhaling bronchodilators.

? 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.

? 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	The first affiliated hospital of wenzhou medical university	Wenzhou	Zhejiang

Sponsors (11)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University	Henan Provincial People's Hospital, Shanghai Fengxian District Central Hospital, Shanghai Minhang Central Hospital, Shanghai Zhongshan Hospital, Shantou University Medical College, Shenzhen University, Sun Med IT(ShangHai) Co. Ltd, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Fujian Medical University, Xibei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors and pathogenesis of of COPD	To establish a cohort of copd patients and high-risk population; To establish a multi-factor risk factor model for copd, and screen 5-10 risk factors related to the occurrence and development of COPD.	From date of participation in project until December 31, 2022
Secondary	Clinical bioinformatics database for COPD	To find 1-2 susceptibility genes closely related to COPD through gene and epigenetic studies combined with clinical bioinformatics analysis and genomic research ; To find 3-5 biomarkers closely related to COPD through protein and metabolomics studies as well as clinical bioinformatics analysis.	From date of participation in project until December 31, 2022
Secondary	Biological library of COPD	To verify the identified susceptibility genes and biomarkers in the existing COPD cohort, and then expand to be verified outside the cohort, to verify 5-7 related susceptibility genes and biomarkers; To further explore the pathogenesis of COPD by conducting preliminary mechanism studies on the discovered susceptibility genes and biomarkers combined with big data analysis; To build a unified copd data collection and sharing platform between local hospitals to achieve real-time monitoring of statistical analysis.	From date of participation in project until December 31, 2022