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| ID | Type | Description | Link |
|---|---|---|---|
| ESR-16-12485 | Other Identifier | China-Japan Friendship Hospital, Ministry of Health |
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The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices and to monitor and improve clinical outcomes in this disease.
This is a 5-year multi-center observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 3000) and GOLD 0 subjects (n= 800).Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct pulmonary function test, HRCT.Patients must meet all the inclusion criteria and none of the exclusion criteria.No additional investigational drugs will be applied to the patients. Full analysis set will be used for all analyses. Missing data will be analysed as it is. Statistical analysis will be conducted by epidemiology & statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used.Questionnaire variables will be checked before data entry.During the study, PI will be in charge of the monitoring of the whole procedure. Two working group will do the data cleaning and data analysing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD group | The post-bronchodilator FEV1/FVC ratio < 0.70 was used as definition of COPD, which was proposed by the Global Initiative for Chronic Obstructive Lung Disease |
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| GOLD 0 group | GOLD 0 is defined as having chronic respiratory symptoms and/or high risk factors, but without airflow (post-BD FEV1/FVC ≥ 0.7). Chronic respiratory symptoms is defined as chronic cough, phlegm production, chest tightness, short of breath, dyspnea, wheeze, ect. High risk factors is defined as cigarette smoking, passive smoking, occupational exposures, bio-fuels exposures ect. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPD group | Other | The treatments will be determined by their treating physicians and no additional investigational drugs will be applied to the patients included in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| COPD-related mortality and all-cause mortality | COPD-related mortality and all-cause mortality | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| COPD exacerbation rate per year | COPD exacerbation rate per year | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Tier 2 or tier 3 hospitals in China
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| Name | Affiliation | Role |
|---|---|---|
| Kewu Huang, M.D. | Beijing Chao Yang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University | Beijing | Beijing Municipality | China |
no plan to share IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2016 | Dec 4, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2017 | Jul 26, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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whole blood and sputum
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |