Protein; DiseaseNCT05376618
Pilot Study on Proteomics of Erythrocyte Proteins in Patients With COPD Based on TMT Technology
An observational study of Protein; Disease, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein; Disease
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be an outpatient-based case-control study. 15 stable COPD patients and 15 healthy individuals will be recruited.
Who may be able to join
- Age from 40 to 80 years old; gender is not limited.
- Stable COPD
- Sign the informed consent with the willingness of obeying the protocol. -
Who cannot join
- 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) -
- control group Inclusion criteria
Show all 13Show fewer
- Age from 40 to 80 years old; gender is not limited.
- Sign the informed consent with the willingness of obeying the protocol. - Exclusion criteria
- <!-- -->
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: Pilot Study on Proteomics of Erythrocyte Proteins in Patients With Chronic Obstructive Pulmonary Disease Based on TMT Technology
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.
- Conditions
- Protein; Disease
- Being tested
- no intervention
- Keywords
- copd, erythrocyte, proteomics
- Medical subject headings
- Disease, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| stable COPD | Not described Receives: Other: no intervention | |
| Healthy | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021-7-15 to 2022-7-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 Jul 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein; DiseaseStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376618
- Sponsor's protocol ID
- 2021-KY-060--01
- Status last verified
- Jul 2021
- First submitted
- 11 May 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Proteomics of Erythrocyte Proteins in Patients With Chronic Obstructive Pulmonary Disease Based on TMT Technology
- ClinicalTrials.gov ID
- NCT05376618
- Acronym / sponsor ID
- 2021-KY-060--01
- Conditions
- Protein; Disease
- Keywords
- copd, erythrocyte, proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable COPD | – | Other: no intervention |
| Healthy | – | Other: no intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be an outpatient-based case-control study. 15 stable COPD patients and 15 healthy individuals will be recruited.
Key inclusion criteria (3 listed)
Key exclusion criteria (13 listed)
- control group Inclusion criteria
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Healthy, stable COPD |
Primary outcome
Protein biomarkers in erythrocyte predicting rapid decline of lung function
Time frame: 2021-7-15 to 2022-7-15
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Protein; Disease, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein biomarkers in erythrocyte predicting rapid decline of lung function (time frame: 2021-7-15 to 2022-7-15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.