- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05028985
Early COPD for China Pulmonary Health Study Stage II (EC-CPHS)
29. august 2021 opdateret af: Chen Wang, China-Japan Friendship Hospital
A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II
Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including "China Pulmonary Health study", "The Cohort Study for Chronic Obstructive Pulmonary Disease in China" and "Acute Exacerbation of COPD Patient Registry in China" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome).
We propose to establish a new standard for COPD stages and subtypes.
By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD.
This project can bring a new insight and scientific evidence for COPD treatment.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
400
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Chen Wang
- Telefonnummer: +86 010 69156477
- E-mail: cyh-birm@263.net
Studiesteder
-
-
-
Beijing, Kina
- Rekruttering
- Peking University Third Hospital
-
Kontakt:
- Yahong Chen
-
Beijing, Kina
- Rekruttering
- China-Japan Friendship Hospital
-
Kontakt:
- Ting Yang
-
Beijing, Kina
- Rekruttering
- Capital Medical University
-
Beijing, Kina
- Rekruttering
- Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
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Kontakt:
- Jing Wang
-
Shanghai, Kina
- Rekruttering
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
-
Kontakt:
- Weining Xiong
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Rekruttering
- Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
early COPD patients and healthy controls
Beskrivelse
Inclusion Criteria:
- younger than 50 years
- smoking more than 10 pack-years
- early airflow limitation(post-bronchodilator FEV1/FVC< lower limit of normal)
Exclusion Criteria:
- cancer
- other respiratory diseases
- mental illness
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
early COPD patients
younger than 50 years with 10 or more pack-years smoking history and any of these abnormalities: 1) early airflow limitation (post-bronchodilator forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC) < lower limit of normal), 2) compatible CT abnormalities, 3) rapid decline in FEV1 (≥60 ml/yr).
|
Healthy people
healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
FEV1 annual decline in clinical practice
Tidsramme: 2021.1-2024.12
|
FEV1 measured by portable spirometry can reflect the progression of early COPD.
|
2021.1-2024.12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
dyspnea symptoms
Tidsramme: 2021.1-2024.12
|
Severity of dyspnea is positively correlated with COPD severity.
|
2021.1-2024.12
|
frequency of COPD acute exacerbation
Tidsramme: 2021.1-2024.12
|
The frequency of COPD acute exacerbation refers to the number of acute exacerbations per year.
|
2021.1-2024.12
|
chest imaging changes
Tidsramme: 2021.1-2024.12
|
Emphysema and obstruction in small airway will be evaluated by chest computed tomography(CT).
|
2021.1-2024.12
|
systemic complications
Tidsramme: 2021.1-2024.12
|
Whether there are systemic complications is related to the prognosis of patients.
|
2021.1-2024.12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yahong Chen, Peking University Third Hospital
- Studiestol: Chen Wang, Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
- Ledende efterforsker: Ting Yang, China-Japan Friendship Hospital
- Ledende efterforsker: Jing Wang, Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
- Ledende efterforsker: Huahao Shen, Second Affiliated Hospital of Zhejiang University School of Medicine
- Ledende efterforsker: Wei Wang, Capital Medical University
- Ledende efterforsker: Weining Xiong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2021
Primær færdiggørelse (Forventet)
1. januar 2025
Studieafslutning (Forventet)
1. december 2025
Datoer for studieregistrering
Først indsendt
3. juni 2021
Først indsendt, der opfyldte QC-kriterier
29. august 2021
Først opslået (Faktiske)
31. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 82090011
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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