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

NCT ID: NCT04183530

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2024-12-30

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.

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.

Conditions

Copd; Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Yang Jin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Geng, Master

Role: CONTACT

Phone: +8618696152606

Email: dr.geng116@gmail.com

Facility Contacts

Yang Jin, MD

Role: primary

Other Identifiers

2018S1105-1

Identifier Type: -

Identifier Source: org_study_id