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

The Individualized Accurate Diagnosis and Treatment, as Well as the Prevention of Acute Exacerbation of Chronic Objective Pulmonary Disease(COPD) Based on Multidimensional Data

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.

Study Overview

• Status: Recruiting
• Conditions: Copd; Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Wei Geng, Master; Phone Number: +8618696152606; Email: dr.geng116@gmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients and healthy people.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The metabolomics analysis of participates' urine or stool	Predominately include metabolic target analysis, metabolic profiling analysis	through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2019
• Primary Completion (ANTICIPATED): October 16, 2022
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (ACTUAL): December 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2018S1105-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No