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Active, Not Recruiting

NCT Number: NCT02755441

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Idiopathic Pulmonary Fibrosis Disease Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gentofte Hospital, Hellerup, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease progression or mortality

    Time frame: 1 year

    Number of patients who fulfil any of the following: disease progression or death

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nils Hoyer

Other

Collaborators

  • Aarhus University Hospital
  • Nordic Bioscience A/S

Registry information

Official study title

Pulmonary Fibrosis Biomarker Cohort (PFBIO)

Acronym: PFBIO

Important dates

Study start
2016
Primary completion
2023
Study completion
2028
First posted
Apr 29, 2016
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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