Chronic Obstructive Pulmonary DiseaseNCT05069194
Study on the Etiology, Risk Factors and Pathogenesis of COPD Based on Clinical Bioinformatics
An observational study of Chronic Obstructive Pulmonary Disease, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 13,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were recruited from Shanghai City, Wenzhou City, Quanzhou City, Zhengzhou City and Xi'an City.
Who may be able to join
- 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.
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- 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.
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, 325000
chengshui Chen
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of participation in project until December 31, 2022
Secondary outcomes (2)
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.
Measured: From date of participation in project until December 31, 2022
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.
Measured: From date of participation in project until December 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 Dec 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- ChengShui Chen, Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069194
- Sponsor's protocol ID
- 2016YFC1304000
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Etiology, Risk Factors and Pathogenesis ofCOPD Based on Clinical Bioinformatics
- ClinicalTrials.gov ID
- NCT05069194
- Acronym / sponsor ID
- 2016YFC1304000
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from Shanghai City, Wenzhou City, Quanzhou City, Zhengzhou City and Xi'an City.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors and pathogenesis of of COPD
Time frame: From date of participation in project until December 31, 2022
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.
2 secondary outcomes
Clinical bioinformatics database for COPD
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChengShui Chen study chair
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yang (0086-13777780071, taiyang2630@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors and pathogenesis of of COPD (time frame: From date of participation in project until December 31, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.