Pulmonary Fibrosis Biomarker Cohort - a Prospective Cohort of Incident Patients With IPF
PFBIO
1 other identifier
observational
450
1 country
2
Brief Summary
Incident patients with idiopathic pulmonary fibrosis (IPF) in Denmark will be offered inclusion and followed up for up to 5 years with measurements of blood biomarkers and measurements of disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedDecember 22, 2023
December 1, 2023
7.7 years
April 19, 2016
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease progression or mortality
Number of patients who fulfil any of the following: disease progression or death
1 year
Secondary Outcomes (7)
Hospitalizations
1 year
Exacerbations
1 year
Lung function tests
1 year
Mortality
1 year
Change in quality of life
1 year
- +2 more secondary outcomes
Eligibility Criteria
Incidental patients diagnosed with idiopathic pulmonary fibrosis (IPF) at Gentofte hospital and Aarhus university hospital are screened for inclusion
You may qualify if:
- Diagnosis of idiopathic pulmonary fibrosis according to the 2011 guidelines by the American Thoracic Cosicety (ATS) and European Respiratory Society (ERS)
You may not qualify if:
- Age lower than 18 years
- Unable to provide informed consent to participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nils Hoyerlead
- Aarhus University Hospitalcollaborator
- Nordic Bioscience A/Scollaborator
Study Sites (2)
Gentofte Hospital
Hellerup, Copenhagen, 2900, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (2)
Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PMID: 21471066BACKGROUNDHoyer N, Prior TS, Bendstrup E, Shaker SB. Diagnostic delay in IPF impacts progression-free survival, quality of life and hospitalisation rates. BMJ Open Respir Res. 2022 Jul;9(1):e001276. doi: 10.1136/bmjresp-2022-001276.
PMID: 35798532DERIVED
Biospecimen
Serum and EDTA-plasma is collected from all patients at 0, 6 and 12 months, 2 years, 3 years, 4 years and 5 years. Blood DNA and RNA tubes are collected for all patients at one site (Gentofte hospital)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nils Hoyer, MD
Gentofte Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 29, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2023
Study Completion (Estimated)
December 1, 2028
Last Updated
December 22, 2023
Record last verified: 2023-12