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Idiopathic Pulmonary FibrosisPFBIONCT02755441

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

An observational study of Idiopathic Pulmonary Fibrosis, run by Nils Hoyer at 2 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
How many people
450 participants
Where
2 sitesDenmark
Study dates
Apr 2016to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Incidental patients diagnosed with idiopathic pulmonary fibrosis (IPF) at Gentofte hospital and Aarhus university hospital are screened for inclusion

Who may be able to join

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

Who cannot join

  • Age lower than 18 years
  • Unable to provide informed consent to participation

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Gentofte Hospital

    Hellerup, Copenhagen, 2900

Other trials in Denmark

About this study

Official title: Pulmonary Fibrosis Biomarker Cohort (PFBIO)

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.

Read the 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.

Keywords
Diagnosis, Prognosis, Biomarker
Medical subject headings
Idiopathic Pulmonary Fibrosis, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease progression or mortality

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

    Measured: 1 year

Secondary outcomes (7)

  1. Hospitalizations

    Number of respiratory and non-respiratory hospitalizations

    Measured: 1 year

  2. Exacerbations

    Number of acute exacerbations of idiopathic pulmonary fibrosis

    Measured: 1 year

  3. Lung function tests

    Reduction in diffusion capacity (DLCO) and forced vital capacity (FVC)

    Measured: 1 year

  4. Mortality

    All-cause and disease-specific mortality

    Measured: 1 year

  5. Change in quality of life

    Change in St. George Respiratory Questionnaire, symptom scores

    Measured: 1 year

  6. 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

    Measured: 1 year

  7. Progression in serum/plasma biomarker levels

    Increase or decrease in serum/plasma biomarker levels.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755441
Sponsor's protocol ID
PFBIO
Acronym
PFBIO
Status last verified
Dec 2023
First submitted
19 Apr 2016
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21471066

  • Hoyer N, Prior TS, Bendstrup E, Shaker SB. Diagnostic delay in IPF impacts progression-free survival, quality of life and hospitalisation rates. BMJ Open Respir Res. 2022 Jul;9(1):e001276. doi: 10.1136/bmjresp-2022-001276.

    PubMed 35798532

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Nils Hoyer at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression or mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755441, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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