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Korean Idiopathic Pulmonary Fibrosis Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04160715
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jong Sun Park, Seoul National University Bundang Hospital

Brief 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.

Condition or disease
Idiopathic Pulmonary Fibrosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Korean Idiopathic Pulmonary Fibrosis Registry
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : December 2026





Primary Outcome Measures :
  1. survival of IPF [ Time Frame: through study completion, an average of 1 year ]
    lung function change (FVC, DLCO)


Secondary Outcome Measures :
  1. survival [ Time Frame: through study completion, an average of 1 year ]
    death rate

  2. acute exacerbation [ Time Frame: through study completion, an average of 1 year ]
    rate of acute exacerbation

  3. incidence of comorbidity [ Time Frame: through study completion, an average of 1 year ]
    incidence of lung cancer


Biospecimen Retention:   Samples With DNA
serum, protein, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with IPF
Criteria

Inclusion Criteria:

  • IPF patients diagnosed by multidisciplinary discussion

Exclusion Criteria:

  • Other interstitial lung diseases except for IPF
  • connective tissue disease-related ILD
  • exposure-related ILD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160715


Contacts
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Contact: Jong Sun Park, MD jspark.im@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact: Jong Sun Park, MD         
Principal Investigator: Jong Sun Park, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Man Pyo Chung, MD Samsung Medical Center

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Responsible Party: Jong Sun Park, Associate professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT04160715    
Other Study ID Numbers: 1.1
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial