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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04183530
Other study ID # 2018S1105-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2019
Est. completion date December 30, 2024

Study information

Verified date November 2021
Source Wuhan Union Hospital, China
Contact Wei Geng, Master
Phone +8618696152606
Email dr.geng116@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 30, 2024
Est. primary completion date October 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The transcriptome analysis of participates' serum or plasma Include the transcriptome data of serum,plasma or exosomes inside through study completion, an average of 1 year
Primary The metabolomics analysis of participates' urine or stool Predominately include metabolic target analysis, metabolic profiling analysis through study completion, an average of 1 year
Primary The proteomics analysis of bronchoalveolar lavage fluid and saliva Differentially expressed proteins between SCOPD and AECOPD which associated with disease progression were analyesd through study completion, an average of 1 year
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