An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Peking University First Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by Peking University First Hospital · Observational
Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Previous studies have found that accelerated loss of forced expiratory volume in 1 second (FEV1.0) in an individual is considered an indicator of developing COPD. This functional predictive system, due to lower sensitivity, is very difficult to discover high-risk population and earlier stage of the disease. The inflammation occurs earlier than the lung function impairment. Therefore, early detection of the inflammation may theoretically predict the occurrence of COPD and thus may guide early intervention.
Proteomics techniques and protein chip techniques provides us high throughput screening method to figure out characteristic inflammatory or metabolic markers of a diseases. It can be used for searching the biomarkers relating to lung function loss. EBC is collected from exhaled gas and is a good non-invasive method for exploring the pathologic process of the airways.
Thus we designed this study to identify potential biomarkers associated with rapid lung function decline. This study is divided into two parts: 1) screening potential biomarkers between stable COPD and healthy individuals; 2) verifying significant biomarkers of first part in a community-based nested case-control population for 2 years.
Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 2,440 is above the median of 150 across 638 observational studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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The FIRST STEP of study will be a outpatient based case-control study. 20 stable COPD patients and 20 healthy individuals will be recruited.
The SECOND STEP of study will be a community based, multi-center,prospective nested case-control designed, which including a total of 24OO study subjects, it will focus on two different communities, which are Shi Cha Hai community, De Sheng Community in Beijing
Inclusion criteria
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Inclusion criteria According to age (+ / - 5 years), gender and smoking, to match healthy volunteers as the control group.
a. with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al); b. had been accepted lung lobectomy or transplantation; c. be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al ); d. Alcoholism, drug or solvents addition; e. Acute respiratory infection in 4 weeks (rhinitis, pharyngitis, acute tracheobronchitis, pneumonia, etc.)
2.SECOND STEP: nested case-control study Inclusion criteria
Exclusion criteria
no intervention
no intervention
no intervention
no intervention
Protein biomarkers in EBC predicting rapid decline of lung function
The study(second part) is to identify the biomarkers screened from the first step and make sure which is associated with rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects.
Time frame: 4 years
Protein biomarkers of EBC between COPD patients and healthy individuals
The first part of study is to screen target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC are to reserved. Proteomics techniques and protein chip techniques were used to screening COPD specific biomarkers.
Time frame: 1 year
Blood biomarkers between COPD patients and healthy individuals
Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.
Time frame: 1 year
Blood biomarkers predicting rapid decline of lung function
Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.
Time frame: 4 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital