Chronic Obstructive Pulmonary DiseaseNCT03120481
Controls for Respiratory Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Idiopathic Pulmonary Fibrosis
- What is being tested?
- no intervation
- How many people
- 1,572 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2017to 28 Feb 2037
- How long will I take part?
- 20 Years
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those who visited the hospital for health check-up, and agree to participate in this study.
Who may be able to join
- 19-90 years old male and female
- underwent health check-up including chest radiography
- obtained informed consent
Who cannot join
- those who showed a significant abnormal finding of chest radiography
- those who reported a significant respiratory symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Healthcare System Gangnam Center
Seoul, Seoul, 06236
Chang-Hoon Lee, M.D., 82-2-2072-4743, kauri670@gmail.com
About this study
Official title: The Registry of Controls for Respiratory Diseases
This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Idiopathic Pulmonary Fibrosis, Nontuberculous Mycobacterium Infection, Bronchiectasis, Lung Cancer
- Being tested
- no intervation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Idiopathic Pulmonary Fibrosis, Mycobacterium Infections, Nontuberculous, Bronchiectasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervationOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Not described Receives: Other: no intervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death
Measured: 20 years
Secondary outcomes (3)
Hospitalization
All cause hospitalization
Measured: 20 years
Respiratory hospitalization
Hospitalization from respiratory causes
Measured: 20 years
Respiratory diseases diagnosis
Respiratory diseases diagnosis
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start10 Apr 2017
- Primary completion28 Feb 2037 (estimated)
- Study completion28 Feb 2037 (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 DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,572 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Lee, Seoul National University Hospital
- Investigators
- Chang-Hoon Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120481
- Sponsor's protocol ID
- 2016-3435
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry of Controls for Respiratory Diseases
- ClinicalTrials.gov ID
- NCT03120481
- Acronym / sponsor ID
- 2016-3435
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Idiopathic Pulmonary Fibrosis, Nontuberculous Mycobacterium Infection, Bronchiectasis, Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,572 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 28 Feb 2037 (estimated)
- Study completion
- 28 Feb 2037 (estimated)
- First posted
- 19 Apr 2017 (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 is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | Other: no intervation |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those who visited the hospital for health check-up, and agree to participate in this study.
Key inclusion criteria (3 listed)
- 19-90 years old male and female
- underwent health check-up including chest radiography
- obtained informed consent
Key exclusion criteria (2 listed)
- those who showed a significant abnormal finding of chest radiography
- those who reported a significant respiratory symptoms
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 intervationno intervention | Other | Normal control |
Primary outcome
Mortality
Time frame: 20 years
Death
3 secondary outcomes
Hospitalization
Time frame: 20 years
Respiratory hospitalization
Time frame: 20 years
Respiratory diseases diagnosis
Time frame: 20 years
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 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Chang-Hoon Lee, M.D. principal investigator
Seoul National University Hospital
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 and Asthma, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 19 Apr 2017. 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 South Korea. 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 Chang-Hoon Lee, M.D. (82-2-2072-4743, kauri670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 20 years). 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 19 Apr 2017.