Chronic Obstructive Pulmonary Disease SevereNCT06198309
Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease Severe, run by Li An at 1 site in China.
Trial summary
This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Adult, Older adult
Study population: A patient with severe chronic obstructive pulmonary disease who visited the Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University since January 2023
Who may be able to join
- Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1/FVC\<70%, FEV1% predicted value ≤ 50% after Bronchiectasis)
- Age\>40 years old
- COPD stable for more than 4 weeks
- Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month
- Patient informed and signed consent form
Who cannot join
- Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis
- Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)
- History of chronic diarrhea or constipation
- History of Gastrointestinal Surgery
- Using probiotics or antibiotics within the past 4 weeks
- No history of using oral hormones or traditional Chinese medicine in the past three months
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
Li An, doctorate, CHN+13681133265, bjzy818@sina.com
About this study
Official title: A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease
This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.
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 |
|---|---|---|
| Frequent exacerbation of COPD | Not described | |
| Non-frequent exacerbation of COPD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve.
According to the Area Under Curve (AUC) of ROC, the largest one has the best predictive performance. When AUC>0.5, the closer it is to 1, the better the predictive performance of the model. When AUC=0.5, it indicates poor model fitting and no potential predictive value.
Measured: A year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 May 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 365 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Li An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li An, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198309
- Sponsor's protocol ID
- al123456
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06198309
- Acronym / sponsor ID
- al123456
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Li AnUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jan 2024 (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.
This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequent exacerbation of COPD | – | – |
| Non-frequent exacerbation of COPD | – | – |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A patient with severe chronic obstructive pulmonary disease who visited the Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University since January 2023
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1/FVC\<70%, FEV1% predicted value ≤ 50% after Bronchiectasis)
- Age\>40 years old
- COPD stable for more than 4 weeks
- Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month
- Patient informed and signed consent form
Key exclusion criteria (7 listed)
- Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis
- Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)
- History of chronic diarrhea or constipation
- History of Gastrointestinal Surgery
- Using probiotics or antibiotics within the past 4 weeks
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
Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve.
Time frame: A year
According to the Area Under Curve (AUC) of ROC, the largest one has the best predictive performance. When AUC>0.5, the closer it is to 1, the better the predictive performance of the model. When AUC=0.5, it indicates poor model fitting and no potential predictive value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
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 Chronic Obstructive Pulmonary Disease Severe, run by Li An 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li An (CHN+13681133265, bjzy818@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve. (time frame: A year). 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 10 Jan 2024.