Pulmonary Fibrosis Biomarker Cohort - a Prospective Cohort of Incident Patients With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

— PFBIO  

Official title:

Pulmonary Fibrosis Biomarker Cohort (PFBIO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02755441
• Other study ID #: PFBIO
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

IPF pathogenesis is complex, including epithelial injury, resident fibroblast-myofibroblast transformation, recruitment of fibrocytes, macrophage activation, and release of numerous cytokines and chemokines. Several of these processes release potential biomarker proteins into the blood stream or onto the epithelial surface where they can be measured. Biomarkers have mainly two potential roles in IPF. Firstly, a diagnostic biomarker would distinguish IPF from other diseases with similar symptoms, facilitating diagnosis and possibly decreasing the need for risky procedures, such as surgical lung biopsy. Secondly, a prognostic biomarker would distinguish rapid progressors from slow progressors, which is difficult today.

This study will prospectively include patients at the two largest centres in Denmark where patients are treated for IPF and has thus a good opportunity to include the majority of incident cases of IPF in Denmark. The blood levels of several promising biomarkers will be measured at baseline and during up to 5 years follow-up. Patients will also be followed up through regular clinical examination and by querying national registries to determine disease progression, mortality, healthcare utilization and selected co-morbidities. The database will be used for determination of risk factors for the outcomes listed above. Sub-group analyses are planned in respect to sex, treatment, radiologic imaging, smoking status, clinical data such as pulmonary function tests, co-morbidities (both pulmonary disease and extra-pulmonary disease), and disease severity at baseline.

A research biobank with blood samples is established from the study population. This biobank, and the database of newly diagnosed IPF patients, will be used for future research in IPF.

The prospectively created database will also be used for future research in IPF.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic pulmonary fibrosis according to the 2011 guidelines by the American Thoracic Cosicety (ATS) and European Respiratory Society (ERS)

Exclusion Criteria:

• Age lower than 18 years

• Unable to provide informed consent to participation

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Gentofte Hospital	Hellerup	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Nils Hoyer	Aarhus University Hospital, Nordic Bioscience A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression or mortality	Number of patients who fulfil any of the following: disease progression or death	1 year
Secondary	Hospitalizations	Number of respiratory and non-respiratory hospitalizations	1 year
Secondary	Exacerbations	Number of acute exacerbations of idiopathic pulmonary fibrosis	1 year
Secondary	Lung function tests	Reduction in diffusion capacity (DLCO) and forced vital capacity (FVC)	1 year
Secondary	Mortality	All-cause and disease-specific mortality	1 year
Secondary	Change in quality of life	Change in St. George Respiratory Questionnaire, symptom scores	1 year
Secondary	Combined end-point of disease progression	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
Secondary	Progression in serum/plasma biomarker levels	Increase or decrease in serum/plasma biomarker levels.	1 year