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

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ClinicalTrials.gov Identifier: NCT02755441
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : November 1, 2021
Aarhus University Hospital
Nordic Bioscience A/S
Information provided by (Responsible Party):
Nils Hoyer, University Hospital, Gentofte, Copenhagen

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.

Condition or disease
Idiopathic Pulmonary Fibrosis

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Fibrosis Biomarker Cohort (PFBIO)
Study Start Date : April 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Primary Outcome Measures :
  1. Disease progression or mortality [ Time Frame: 1 year ]
    Number of patients who fulfil any of the following: disease progression or death

Secondary Outcome Measures :
  1. Hospitalizations [ Time Frame: 1 year ]
    Number of respiratory and non-respiratory hospitalizations

  2. Exacerbations [ Time Frame: 1 year ]
    Number of acute exacerbations of idiopathic pulmonary fibrosis

  3. Lung function tests [ Time Frame: 1 year ]
    Reduction in diffusion capacity (DLCO) and forced vital capacity (FVC)

  4. Mortality [ Time Frame: 1 year ]
    All-cause and disease-specific mortality

  5. Change in quality of life [ Time Frame: 1 year ]
    Change in St. George Respiratory Questionnaire, symptom scores

  6. Combined end-point of disease progression [ Time Frame: 1 year ]
    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

  7. Progression in serum/plasma biomarker levels [ Time Frame: 1 year ]
    Increase or decrease in serum/plasma biomarker levels.

Biospecimen Retention:   Samples With DNA

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Incidental patients diagnosed with idiopathic pulmonary fibrosis (IPF) at Gentofte hospital and Aarhus university hospital are screened for inclusion

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

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): NCT02755441

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Contact: Nils Hoyer, MD +45-38674200 nils.hoyer@regionh.dk

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Gentofte Hospital Recruiting
Hellerup, Copenhagen, Denmark, 2900
Contact: Nils Hoyer, MD    +45-38674200    nils.hoyer@regionh.dk   
Aarhus University Hospital Active, not recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
Nils Hoyer
Aarhus University Hospital
Nordic Bioscience A/S
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Principal Investigator: Nils Hoyer, MD Gentofte Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nils Hoyer, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02755441    
Other Study ID Numbers: PFBIO
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nils Hoyer, University Hospital, Gentofte, Copenhagen:
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases