NCT05376618

Brief Summary

Chronic obstructive pulmonary disease (COPD), a common and complex disease characterized by persistent airflow limitation, is a leading cause of mortality worldwide. COPD and its comorbidity are associated with hypoxia condition. Further investigations on the cellular and molecular aspects of hypoxia in COPD should help to reveal the mechanisms underlying the development of this disease. Dysfunction of the erythrocyte, a main medium to transport oxygen through the blood, contributes to the prognosis and severity of COPD through hypoxia. It is proposed that dysregulated proteins in erythrocytes that impair oxygen transport may be involved in the development of COPD. However, a comprehensive study on altered proteins of erythrocytes in COPD is still lacking. Proteomics techniques and protein chip techniques provide a high throughput screening method to figure out characteristic inflammatory or metabolic markers of diseases. Therefore, this study is to evaluate the clinical significance of differential erythrocyte proteins in the course of COPD disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

March 15, 2024

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

May 11, 2022

Last Update Submit

March 12, 2024

Conditions

Keywords

copderythrocyteproteomics

Outcome Measures

Primary Outcomes (1)

  • Protein biomarkers in erythrocyte predicting rapid decline of lung function

    The study is to identify the biomarkers and make sure which is associated with rapid decline of lung function. The study will include a total of 30 study subjects.

    2021-7-15 to 2022-7-15

Study Arms (2)

stable COPD

Other: no intervention

Healthy

Other: no intervention

Interventions

no intervention

Healthystable COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be an outpatient-based case-control study. 15 stable COPD patients and 15 healthy individuals will be recruited.

You may qualify if:

  • Age from 40 to 80 years old; gender is not limited.
  • Stable COPD
  • Sign the informed consent with the willingness of obeying the protocol. -

You may not qualify if:

  • Subjects with known other chronic respiratory diseases except for COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
  • Subjects had been accepted lung lobectomy or transplantation;
  • Subjects be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
  • Alcoholism, drug or solvents addition;
  • Acute exacerbation COPD patients (AECOPD) -
  • Age from 40 to 80 years old; gender is not limited.
  • <!-- -->
  • Subjects with known other chronic respiratory diseases (such as COPD, asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
  • Subjects had been accepted lung lobectomy or transplantation;
  • Subjects be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
  • Alcoholism, drug or solvents addition;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

DiseasePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

July 15, 2021

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

March 15, 2024

Record last verified: 2021-07

Locations