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

NCT04183530 | Unknown

• 1 other identifier: 2018S1105-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients and healthy people.

You may qualify if:

• Patient has signed informed consent.
• Patients diagnosed with COPD or fully healthy participants.

You may not qualify if:

• Tumor disease.
• Heart disease.
• Thyroid disease.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Geng, Master

CONTACT

+8618696152606; dr.geng116@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 3, 2019
• Study Start: October 16, 2019
• Primary Completion: October 16, 2022
• Study Completion: December 30, 2024
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

CN (1)