MedDataX Logo

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

NCT ID: NCT02755441

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Fibrosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diagnosis Prognosis Biomarker

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Nordic Bioscience A/S

INDUSTRY

Sponsor Role collaborator

Nils Hoyer

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nils Hoyer

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nils Hoyer, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gentofte Hospital

Hellerup, Copenhagen, Denmark

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21471066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35798532 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PFBIO

Identifier Type: -

Identifier Source: org_study_id