- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05069194
Study on the Etiology, Risk Factors and Pathogenesis of COPD Based on Clinical Bioinformatics
Study on the Etiology, Risk Factors and Pathogenesis ofCOPD Based on Clinical Bioinformatics
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Li Yang
- Phone Number: 0086-13777780071
- Email: taiyang2630@163.com
Study Locations
-
-
Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Contact:
- chengshui Chen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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COPD
Patients with chronic obstructive pulmonary disease
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High Risk
People who do not suffer from COPD, but have high risk factor for COPD.
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Health
People who do not suffer from COPD and do not have a high risk factor for COPD either.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors and pathogenesis of of COPD
Time Frame: From date of participation in project until December 31, 2022
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|
From date of participation in project until December 31, 2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical bioinformatics database for COPD
Time Frame: From date of participation in project until December 31, 2022
|
|
From date of participation in project until December 31, 2022
|
Biological library of COPD
Time Frame: From date of participation in project until December 31, 2022
|
|
From date of participation in project until December 31, 2022
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: ChengShui Chen, First Affiliated Hospital of Wenzhou Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016YFC1304000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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