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

NCT05069194 | Unknown

• 1 other identifier: 2016YFC1304000
• Study Type: observational
• Target: 13,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Risk factors and pathogenesis of of COPD

  1. To establish a cohort of copd patients and high-risk population; 2. 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 Outcomes (2)

• Clinical bioinformatics database for COPD

  From date of participation in project until December 31, 2022

• Biological library of COPD

  From date of participation in project until December 31, 2022

Study Arms (3)

COPD

Patients with chronic obstructive pulmonary disease

High Risk

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

Health

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from Shanghai City, Wenzhou City, Quanzhou City, Zhengzhou City and Xi'an City.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The first affiliated hospital of wenzhou medical university

Wenzhou, Zhejiang, 325000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood，bronchial epithelium,sputum,bronchial alveolar lavage,lung tissue ,mouse

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ChengShui Chen

  First Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Central Study Contacts

Li Yang

CONTACT

0086-13777780071; taiyang2630@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: October 6, 2021
• Study Start: December 10, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-01

Locations

CN (1)