CopdCOPDNCT04183530
The Individualized Accurate Diagnosis and Treatment of Chronic Objective Pulmonary Disease(COPD) Patients Based on Multidimensional Data
An observational study of Copd and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2019to 30 Dec 2024
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients and healthy people.
Who may be able to join
- Patient has signed informed consent.
- Patients diagnosed with COPD or fully healthy participants.
Who cannot join
- Tumor disease.
- Heart disease.
- Thyroid disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yang Jin, MD
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The transcriptome analysis of participates' serum or plasma
Include the transcriptome data of serum，plasma or exosomes inside
Measured: through study completion, an average of 1 year
The metabolomics analysis of participates' urine or stool
Predominately include metabolic target analysis, metabolic profiling analysis
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start16 Oct 2019
- Primary completion16 Oct 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183530
- Sponsor's protocol ID
- 2018S1105-1
- Acronym
- COPD
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2019
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Individualized Accurate Diagnosis and Treatment, as Well as the Prevention of Acute Exacerbation of Chronic Objective Pulmonary Disease(COPD) Based on Multidimensional Data
- ClinicalTrials.gov ID
- NCT04183530
- Acronym / sponsor ID
- COPD / 2018S1105-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 16 Oct 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Dec 2019 (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) 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients and healthy people.
Key inclusion criteria (2 listed)
- Patient has signed informed consent.
- Patients diagnosed with COPD or fully healthy participants.
Key exclusion criteria (3 listed)
- Tumor disease.
- Heart disease.
- Thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The transcriptome analysis of participates' serum or plasma
Time frame: through study completion, an average of 1 year
Include the transcriptome data of serum，plasma or exosomes inside
The metabolomics analysis of participates' urine or stool
Time frame: through study completion, an average of 1 year
Predominately include metabolic target analysis, metabolic profiling analysis
The proteomics analysis of bronchoalveolar lavage fluid and saliva
Time frame: through study completion, an average of 1 year
Differentially expressed proteins between SCOPD and AECOPD which associated with disease progression were analyesd
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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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.
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 Copd and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Geng, Master (+8618696152606, dr.geng116@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The transcriptome analysis of participates' serum or plasma (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 16 Nov 2021.