The Individualized Accurate Diagnosis and Treatment of Chronic Objective Pulmonary Disease(COPD) Patients Based on Multidimensional Data

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04183530
Collaborator
(none)
1,000
1
62.5
16

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease (COPD) is known as progressive lung disease and the fourth leading cause of death worldwide. Despite valuable efforts, there is still no Individualized accurate diagnostic and prognostic tool for COPD. Hence, the investigators' research integrated multi-dimensional data of COPD patients, which may provide an invaluable bioinformatic resource for understanding the underlying molecular alterations that drive disease progression, with the goal of developing individualized accurate diagnostic and therapeutic inventions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic obstructive pulmonary disease (COPD) is known as progressive lung disease and the fourth leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) is an important event of disease progression worsening in airway function and respiratory symptoms, bringing about respiratory failure, and increasing the rates of mortality. Despite valuable efforts, there is still no Individualized accurate diagnostic and prognostic tool for COPD. In this context, the investigators are to perform comprehensive transcriptomic, proteomic, metabonomic and exosome characterization of COPD patients and healthy controls. Biological samples of COPD participants, including blood, urine, stool, saliva, bronchoalveolar lavage fluid and clinical characteristics are going to be collected from the remaining materials of the routine clinical examination. And samples of healthy controls will be collected from the rest of the healthy examination practice. By integrating the multi-dimensional data, the investigators aim to elucidate the impact of molecular alterations driving phenotypic variation and to delineate the mechanisms of AECOPD for prospective exploration of personalized, precision-based clinical care.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Individualized Accurate Diagnosis and Treatment, as Well as the Prevention of Acute Exacerbation of Chronic Objective Pulmonary Disease(COPD) Based on Multidimensional Data
    Actual Study Start Date :
    Oct 16, 2019
    Anticipated Primary Completion Date :
    Oct 16, 2022
    Anticipated Study Completion Date :
    Dec 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    SCOPD

    Participants with stable COPD diagnosed according to GOLD criteria and hasn't encountered acute exacerbations in the past six months, generally include outpatient clinical patient and community patients.

    AECOPD

    Participants with COPD diagnosed according to GOLD criteria and suffered from acute exacerbations, characterized by worsening clinical symptoms(such as acute worsening of dyspnea, and/or cough and sputum production, and/or increased sputum purulence) and positive laboratory biomarkers suggesting AECOPD (such as serum CRP and serum neutrophilia or eosinophilia) at the time of registering into the group, particularly include inpatient.

    Smoking healthy controls

    Participants with a smoking history of more than ten years and was in good health, characterized by negative chest radiograph and negative laboratory tests for cardiac, pulmonary or hematologic disorders, and so on.

    Non smoking healthy controls

    Participants without a smoking history and was in good health, characterized by negative chest radiograph and negative laboratory tests for cardiac, pulmonary or hematologic disorders, and so on.

    Outcome Measures

    Primary Outcome Measures

    1. The transcriptome analysis of participates' serum or plasma [through study completion, an average of 1 year]

      Include the transcriptome data of serum,plasma or exosomes inside

    2. The metabolomics analysis of participates' urine or stool [through study completion, an average of 1 year]

      Predominately include metabolic target analysis, metabolic profiling analysis

    3. The proteomics analysis of bronchoalveolar lavage fluid and saliva [through study completion, an average of 1 year]

      Differentially expressed proteins between SCOPD and AECOPD which associated with disease progression were analyesd

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Patient has signed informed consent.

    2. Patients diagnosed with COPD or fully healthy participants.

    Exclusion Criteria:
    1. Tumor disease.

    2. Heart disease.

    3. Thyroid disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430000

    Sponsors and Collaborators

    • Wuhan Union Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yang Jin, Professor, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04183530
    Other Study ID Numbers:
    • 2018S1105-1
    First Posted:
    Dec 3, 2019
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021