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 : March 5, 2020
|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Early Diagnosis of Pulmonary Fibrosis|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
- Disease progression or mortality [ Time Frame: 1 year ]Number of patients who fulfil any of the following: disease progression or death
- Hospitalizations [ Time Frame: 1 year ]Number of respiratory and non-respiratory hospitalizations
- Exacerbations [ Time Frame: 1 year ]Number of acute exacerbations of idiopathic pulmonary fibrosis
- Lung function tests [ Time Frame: 1 year ]Reduction in diffusion capacity (DLCO) and forced vital capacity (FVC)
- Mortality [ Time Frame: 1 year ]All-cause and disease-specific mortality
- Quality of life [ Time Frame: 1 year ]Change in St. George Respiratory Questionnaire, symptom scores
- 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
- 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)
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
|Contact: Nils Hoyer, MDfirstname.lastname@example.org|
|Hellerup, Copenhagen, Denmark, 2900|
|Contact: Nils Hoyer, MD +45-38674200 email@example.com|
|Aarhus University Hospital||Active, not recruiting|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Nils Hoyer, MD||Gentofte Hospital|