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Early COPD for China Pulmonary Health Study Stage II

NCT ID: NCT05028985

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease

Detailed Description

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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.

Conditions

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Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Healthy people

healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Wang

Study Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen Wang

Role: STUDY_CHAIR

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

Ting Yang

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Jing Wang

Role: PRINCIPAL_INVESTIGATOR

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

Huahao Shen

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Zhejiang University School of Medicine

Wei Wang

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Yahong Chen

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Weining Xiong

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

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Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Capital Medical University

Beijing, , China

Site Status RECRUITING

China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Wang

Role: CONTACT

Phone: +86 010 69156477

Email: [email protected]

Facility Contacts

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HuaHao Shen

Role: primary

Wei Wang

Role: primary

Ting Yang

Role: primary

Jing Wang

Role: primary

Yahong Chen

Role: primary

Weining Xiong

Role: primary

Other Identifiers

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82090011

Identifier Type: -

Identifier Source: org_study_id