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Early Diagnosis of Pulmonary Fibrosis - Use of Biomarkers in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02755441
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nils Hoyer, University Hospital, Gentofte, Copenhagen

Brief Summary:
All incident cases of idiopathic pulmonary fibrosis (IPF) in Denmark will be offered inclusion during a 5 year period 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:

Pulmonary fibrosis can be secondary to connective-tissue disease, environmental exposure, or drug toxicity, but it can also appear sporadically without any known cause, i.e. idiopathic interstitial pneumonitis (IIP). Idiopathic pulmonary fibrosis (IPF) is the commonest IIP and usually follows a rapidly progressive course with a short median survival time.

IPF pathogenesis is believed to be 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 all patients at the two 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 such as malignancy. The database will be used for determination of risk factors for the outcomes listed above. Sub-group analyses are planned in respect to sex, radiologic imaging at baseline (e.g. honeycombing), smoking status, co-morbidities (both pulmonary disease and extra-pulmonary disease), and disease severity at baseline.

A research biobank with regular 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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Pulmonary Fibrosis
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021





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. 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)



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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
All incidental patients diagnosed with idiopathic pulmonary fibrosis (IPF) at Gentofte hospital and Aarhus university hospital are screened for inclusion
Criteria

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
  • Radiological, histological, or clinical findings incompatible with a diagnosis of idiopathic pulmonary fibrosis
  • Unable to provide informed consent to participation
  • Participation in clinical trials investigating novel anti-fibrotic therapies that are not yet approved for treatment of IPF

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


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

Locations
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Denmark
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
Investigators
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Principal Investigator: Nils Hoyer, MD Gentofte Hospital

Publications:
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Responsible Party: Nils Hoyer, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02755441     History of Changes
Other Study ID Numbers: PFBIO
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nils Hoyer, University Hospital, Gentofte, Copenhagen:
Diagnosis
Prognosis
Biomarker
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial