Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay
1 other identifier
observational
300
1 country
2
Brief Summary
Patients with newly diagnosed IPF are investigated for the diagnostic delay before a diagnosis of IPF is made.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 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
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedDecember 22, 2023
December 1, 2023
6.8 years
May 10, 2016
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who fulfil any of the following: disease progression or death
1 year
Secondary Outcomes (6)
Number of patients who fulfill any of the following: decrease in lung function, reduced walking distance at 6 minutes walking test, increased need for supplementary oxygen, hospitalization
1 year
All-cause and disease-specific mortality
1 year
Number of respiratory and non-respiratory hospitalizations
1 year
Decrease in walking distance at the 6 minute walking test
1 year
Change in St. George Respiratory Questionnaire symptom scores
1 year
- +1 more secondary outcomes
Other Outcomes (1)
Diagnostic delays
1 year
Eligibility Criteria
All incident patients with IPF at Gentofte hospital and Aarhus university hospital.
You may qualify if:
- Diagnosis of IPF according to international guidelines
You may not qualify if:
- Unable to provide written informed consent
- Age below 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nils Hoyerlead
- Aarhus University Hospitalcollaborator
Study Sites (2)
Gentofte Hospital
Hellerup, Copenhagen, 2800, 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, Wilcke T, Shaker SB. Risk factors for diagnostic delay in idiopathic pulmonary fibrosis. Respir Res. 2019 May 24;20(1):103. doi: 10.1186/s12931-019-1076-0.
PMID: 31126287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 13, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2022
Study Completion (Estimated)
December 1, 2028
Last Updated
December 22, 2023
Record last verified: 2023-12