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

Sponsor
First Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05069194
Collaborator
Shanghai Zhongshan Hospital (Other), The Second Affiliated Hospital of Fujian Medical University (Other), The First Affiliated Hospital of Zhengzhou University (Other), Xibei Hospital (Other), Henan Provincial People's Hospital (Other), Shenzhen University (Other), Shantou University Medical College (Other), Shanghai Minhang Central Hospital (Other), Shanghai Fengxian District Central Hospital (Other), Sun Med IT(ShangHai) Co. Ltd (Other)
13,000
1
60.7
214.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    13000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on the Etiology, Risk Factors and Pathogenesis ofCOPD Based on Clinical Bioinformatics
    Actual Study Start Date :
    Dec 10, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Risk factors and pathogenesis of of COPD [From date of participation in project until December 31, 2022]

      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.

    Secondary Outcome Measures

    1. Clinical bioinformatics database for COPD [From date of participation in project until December 31, 2022]

      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.

    2. Biological library of COPD [From date of participation in project until December 31, 2022]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The first affiliated hospital of wenzhou medical university Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: ChengShui Chen, First Affiliated Hospital of Wenzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05069194
    Other Study ID Numbers:
    • 2016YFC1304000
    First Posted:
    Oct 6, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021