Idiopathic Pulmonary FibrosisNCT04160715
Korean Idiopathic Pulmonary Fibrosis Registry
An observational study of Idiopathic Pulmonary Fibrosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2026
- How long will I take part?
- 5 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with IPF
Who may be able to join
- IPF patients diagnosed by multidisciplinary discussion
Who cannot join
- Other interstitial lung diseases except for IPF
- connective tissue disease-related ILD
- exposure-related ILD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jong Sun Park, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Jong Sun Park, MD
Jong Sun Park, MD
About this study
This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group.
Read the detailed description
Korean ILD Study Group includes investigators of 30 hospitals. Demographic, pulmonary function, laboratory data, chest CT findings and hospital course of IPF patients are collected.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
survival of IPF
lung function change (FVC, DLCO)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
survival
death rate
Measured: through study completion, an average of 1 year
acute exacerbation
rate of acute exacerbation
Measured: through study completion, an average of 1 year
incidence of comorbidity
incidence of lung cancer
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 posted13 Nov 2019
- Study startJan 2016
- Primary completionJan 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Sun Park, Seoul National University Bundang Hospital
- Investigators
- Man Pyo Chung, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160715
- Sponsor's protocol ID
- 1.1
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moon SW, Kim SY, Chung MP, Yoo H, Jeong SH, Kim DS, Song JW, Lee HL, Choi SM, Kim YW, Kim YH, Park CS, Park SW, Park JS, Jegal Y, Lee J, Uh ST, Kim TH, Lee JH, Kim YH, Shin B, Lee HK, Yang SH, Lee H, Kim SH, Lee EJ, Choi HS, Shin H, Park YB, Shin JW, Park MS. Longitudinal Changes in Clinical Features, Management, and Outcomes of Idiopathic Pulmonary Fibrosis. A Nationwide Cohort Study. Ann Am Thorac Soc. 2021 May;18(5):780-787. doi: 10.1513/AnnalsATS.202005-451OC.
PubMed 33270528
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Idiopathic Pulmonary Fibrosis Registry
- ClinicalTrials.gov ID
- NCT04160715
- Acronym / sponsor ID
- 1.1
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 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.
This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group.
Detailed description
Korean ILD Study Group includes investigators of 30 hospitals. Demographic, pulmonary function, laboratory data, chest CT findings and hospital course of IPF patients are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with IPF
Key inclusion criteria (1 listed)
- IPF patients diagnosed by multidisciplinary discussion
Key exclusion criteria (3 listed)
- Other interstitial lung diseases except for IPF
- connective tissue disease-related ILD
- exposure-related ILD
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
survival of IPF
Time frame: through study completion, an average of 1 year
lung function change (FVC, DLCO)
3 secondary outcomes
survival
Time frame: through study completion, an average of 1 year
acute exacerbation
Time frame: through study completion, an average of 1 year
incidence of comorbidity
Time frame: through study completion, an average of 1 year
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 13 Nov 2019.
- Derived from this study: PubMed 33270528Moon SW, Kim SY, Chung MP, Yoo H, Jeong SH, Kim DS, Song JW, Lee HL, Choi SM, Kim YW, Kim YH, Park CS, Park SW, Park JS, Jegal Y, Lee J, Uh ST, Kim TH, Lee JH, Kim YH, Shin B, Lee HK, Yang SH, Lee H, Kim SH, Lee EJ, Choi HS, Shin H, Park YB, Shin JW, Park MS. Longitudinal Changes in Clinical Features, Management, and Outcomes of Idiopathic Pulmonary Fibrosis. A Nationwide Cohort Study. Ann Am Thorac Soc. 2021 May;18(5):780-787. doi: 10.1513/AnnalsATS.202005-451OC.
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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.
Jong Sun Park, MD contact
Man Pyo Chung, MD principal investigator
Samsung Medical Center
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 Idiopathic Pulmonary Fibrosis, 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 1 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: looking for participants now, as of the sponsor's last update on 13 Nov 2019. 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 Jong Sun Park, MD (jspark.im@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival of IPF (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160715, which also lists 1 linked publication.
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 13 Nov 2019.