Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank

Idiopathic Pulmonary Fibrosis Clinical Trial

— eurIPFreg  

Official title:

The European IPF Registry - an Internet-based, Pan-European Registry Linked to the European IPF Biobank (eurIPFbank)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02951416
• Other study ID #: EurIPFreg_150609
• Status: Active, not recruiting
• Start date: September 2009
• Est. completion date: January 2040

Study information

• Verified date: February 2024
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Born out of the European Union 7th Framework Programme funded project European IPF Network (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of longitudinal data from IPF patients, including control groups of patients with other lung diseases. The registry was initiated with the intention of creating a permanent and continuously growing record of well defined data on IPF in Europe, in order to increase the chances of finding better treatment options for this devastating disease.

Clinical colleagues who would like to actively participate (both in terms of patient recruitment and data analysis) are invited to contact us (http://www.pulmonary-fibrosis.net/).

Description:

The group's work aims to foster research on Idiopathic Pulmonary Fibrosis (IPF), the most aggressive form of an Idiopathic Interstitial Pneumonia (IIP). Within the eurIPFreg we, the eurIPFreg steering committee and a growing number of external site investigators, aim to describe the natural course of IPF and other IIPs, to identify risk factors that are associated with the evolution of the disease and to sample biomaterials that may serve as underlying basis for translational research activities.

IPF and non-specific interstitial pneumonia (NSIP), as well as the other entities of IIPs (cryptogenic organizing pneumonia, COP; desquamative interstitial pneumonia, DIP; respiratory bronchiolitis interstitial lung disease, RB-ILD; lymphoid interstitial pneumonia, LIP; acute interstitial pneumonia, AIP) are frequently progressive, fibroproliferative diseases of unknown etiology, affecting the lung parenchyma. Patients with IPF have the most devastating prognosis within the group of IIPs, with a median survival rate of 2-3 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: January 2040
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent signed

Exclusion Criteria:

• No informed consent signed

Related Conditions & MeSH terms

• Diffuse Parenchymal Lung Diseases
• Idiopathic Interstitial Pneumonia
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

Other:
• patient registry (observation and biomaterial sampling)
data are collected with patient questionnaires, additionally clinical data are collected at every routine visit and biomaterial is collected

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien	Vienna
France	Centre Hospitalier Universitaire Dijon	Dijon
France	Hopital Bichat Paris	Paris
Germany	Andreas Guenther	Giessen
Germany	Lungenfachklinik Waldhof Elgershausen	Greifenstein
Italy	Università degli Studi di Catania	Catania
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Andreas Guenther

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  United Kingdom, 

References & Publications (2)

Guenther A; European IPF Network. The European IPF Network: towards better care for a dreadful disease. Eur Respir J. 2011 Apr;37(4):747-8. doi: 10.1183/09031936.00012111. No abstract available. — View Citation

Loeh B, Drakopanagiotakis F, Bandelli GP, von der Beck D, Tello S, Cordani E, Rizza E, Barrocu L, Markart P, Seeger W, Guenther A, Albera C. Intraindividual response to treatment with pirfenidone in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2015 Jan 1;191(1):110-3. doi: 10.1164/rccm.201406-1106LE. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical course of patients with Interstitial Lung Diseases (ILD)	change of lung function parameter such as forced vital capacity (FVC), diffusing lung capacity (DLCO) over time mortality symptoms (reported in patients questionnaires)	5 years
Secondary	Comorbidities of patients with ILD	reported in patients and physicians questionnaires	5 years
Secondary	Infections in lung function of patients with ILD	reported in patients and physicians questionnaires	5 years
Secondary	Quality of life of patients with ILD	reported in patients and physicians questionnaires, EQ5D (European quality of life 5-dimensions) questionnaire	5 years
Secondary	Health care utilization of patients with ILD	reported in patients questionnaires	5 years

External Links

•   European IPF Registry website