- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02037828
Exhaled Breathing Condensate (EBC) Features and Lung Function Decline in Chinese Adults
The Screening and Confirmation of Protein Markers Which Can Predict the Decline of Lung Function of Chinese Adults in EBC (Exhaled Breathing Condensate )
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.
- The FIRST STEP is a Case-control study to find target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC and blood are collected. Proteomics techniques and protein chip techniques are to be used to screen COPD specific biomarkers in EBC.
- The SECOND STEP is a community-based nested case-control study to make sure whether the significant biomarkers in first part can predict 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. EBC and blood are collected at the baseline and followed up for two years. Case group is defined as subjects with rapid decline of lung function and new COPD patients. Control group is selected according to 1:1 matching with age and gender.
Tanulmány típusa
Beiratkozás (Várható)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Cheng Zhang, AR, MD
- E-mail: zhangcheng033@163.com
Tanulmányi helyek
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-
Beijing
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Beijing, Beijing, Kína, 100034
- Toborzás
- Peking Universtiy First Hospital
-
Kapcsolatba lépni:
- Zhou Tianyu, PHD
- E-mail: zty2712@hotmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
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
Leírás
1. FIRST STEP:
Case Group:
Inclusion criteria
- age from 40 to 75 year olds; gender is not limited.
- Stable COPD
- Sign the informed consent with willingness of obeying the protocol. Exclusion criteria
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
- had been accepted lung lobectomy or transplantation;
- 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 );
- Alcoholism, drug or solvents addition;
- Acute exacerbation COPD patients (AECOPD)
- Control group:
Inclusion criteria According to age (+ / - 5 years), gender and smoking, to match healthy volunteers as the control group.
- age from 40 to 75 year olds; gender is not limited.
- FEV1 /forced vital capacity (FVC)> 70% after inhaling bronchodilators;
- Sign the informed consent with willingness of obeying the protocol. Exclusion criteria
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
- age from 40 to 75 year olds; gender is not limited.
- have been living in the community for more than 1 years and no plan to move in the near 3 years
- FEV1 / FVC > 70% after inhaling bronchodilators;
- Sign the informed consent with willingness of obeying the protocol.
Exclusion criteria
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
- had been accepted lung lobectomy or transplantation;
- 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 );
- Alcoholism, drug or solvents addition;
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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Stable COPD in STEP1
no intervention
|
Control in STEP 1
no intervention
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Case group in STEP 2
no intervention
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Control group in STEP2
no intervention
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Protein biomarkers in EBC predicting rapid decline of lung function
Időkeret: 4 years
|
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.
|
4 years
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Protein biomarkers of EBC between COPD patients and healthy individuals
Időkeret: 1 year
|
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.
|
1 year
|
Blood biomarkers between COPD patients and healthy individuals
Időkeret: 1 year
|
Peripheral blood will be collected.
Plasma and PBMC will be extracted and stored respectively.
|
1 year
|
Blood biomarkers predicting rapid decline of lung function
Időkeret: 4 year
|
Peripheral blood will be collected.
Plasma and PBMC will be extracted and stored respectively.
|
4 year
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Guangfa Wang, MD, PHD, Peking Universtiy First Hospital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PUCRP201303
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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