- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951416
Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank (eurIPFreg)
The European IPF Registry - an Internet-based, Pan-European Registry Linked to the European IPF Biobank (eurIPFbank)
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/).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andreas Guenther, MD
- Phone Number: +49 64198542502
- Email: andreas.guenther@innere.med.uni-giessen.de
Study Contact Backup
- Name: Jutta Schlegel, PhD
- Phone Number: +49 64198542502
- Email: jutta.schlegel@innere.med.uni-giessen.de
Study Locations
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Vienna, Austria
- Medizinische Universitat Wien
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Dijon, France
- Centre Hospitalier Universitaire Dijon
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Paris, France
- Hopital Bichat Paris
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Giessen, Germany, 35392
- Andreas Guenther
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Greifenstein, Germany
- Lungenfachklinik Waldhof Elgershausen
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Catania, Italy
- Università degli Studi di Catania
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London, United Kingdom
- Royal Brompton Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed consent signed
Exclusion Criteria:
- No informed consent signed
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Idiopathic Pulmonary Fibrosis (IPF)
IPF diagnosis according to the guidelines of 2011 (AJRCCM 2011; 183:788). For patients diagnosed prior to 2011, the criteria of the consensus statement 2000 apply (AJRCCM 2000;161:646). 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
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Non-specific interstitial pneumonia
Non-specific interstitial pneumonia (NSIP) based on the histopathological demonstration of an NSIP pattern. 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
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Cryptogenic organising pneumonia (COP)
COP characterised histologically by an organising pneumonia with intraluminal organising fibrosis in the alveolar ducts and alveolar spaces. 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
|
Acute interstitial pneumonia (AIP)
Histological pattern of diffuse alveolar damage (DAD), characterised by hyaline membranes, alveolar oedema and a marked interstitial and alveolar inflammatory reaction. 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
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Lymphoid interstitial pneumonia (LIP)
Histological pattern of LIP primary or secondary (e.g. rheumatoid arthritis, Sjögren's syndrome, pernicious anaemia, chronic active hepatitis, systemic lupus erythematosus (SLE), primary biliary cirrhosis, myasthenia gravis, severe immune deficiency syndromes (AIDS)). 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
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respiratory bronchiolitis-ILD (RB-ILD)
Histological pattern of RB-ILD or typical clinical and radiological findings.
Patient registry (observation and biomaterial sampling).
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data are collected with patient questionnaires, additionally clinical data are collected at every routine visit and biomaterial is collected
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Desquamative Interstitial Pneumonia
Histological pattern of Desquamative Interstitial Pneumonia (DIP). The picture is similar to RB-ILD, but the distribution pattern is much more homogeneous and does not even have the bronchiolocentric distribution. 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
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Hypersensitivity Pneumonitis
Hypersensitivity Pneumonitis (HP) characterized by exposure to inhaled organic antigens and development of antibodies. Typical clinical and radiological findings, lymphocytosis in bronchoalveolar lavage (BAL) or histology showing HP granulomas. 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
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Sarcoidosis
Histological pattern with sarcoid granulomas or typical clinical and radiological findings with a lymphocytosis in BAL. 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
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Lung Cancer
Histological confirmation of Lung Cancer. Patients will be included as control group. 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
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Chronic Obstructive Pulmonary Disease
Obstructive spirometry and physical history suggesting Chronic Obstructive Pulmonary Disease (COPD). Patients will be included as control group. 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
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Pulmonary Hypertension
Pulmonary Hypertension (PH) diagnosed through right heart catheterisation. Patients will be included as control group. 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
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Sleep Apnea
Sleep Apnea diagnosed by polysomnography. Patients will be included as control group. 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
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Asthma
Asthma diagnosed by positive bronchoprovocation test and typical history or bronchoreversibility in the lung function measurement or through peak flow measurement. Patients will be included as control group. 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
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Control/Health Individuals
Healthy volunteers not suffering from any lung disease as control group.
Patient registry (observation and biomaterial sampling).
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data are collected with patient questionnaires, additionally clinical data are collected at every routine visit and biomaterial is collected
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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clinical course of patients with Interstitial Lung Diseases (ILD)
Time Frame: 5 years
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change of lung function parameter such as forced vital capacity (FVC), diffusing lung capacity (DLCO) over time mortality symptoms (reported in patients questionnaires)
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Comorbidities of patients with ILD
Time Frame: 5 years
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reported in patients and physicians questionnaires
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5 years
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Infections in lung function of patients with ILD
Time Frame: 5 years
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reported in patients and physicians questionnaires
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5 years
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Quality of life of patients with ILD
Time Frame: 5 years
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reported in patients and physicians questionnaires, EQ5D (European quality of life 5-dimensions) questionnaire
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5 years
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Health care utilization of patients with ILD
Time Frame: 5 years
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reported in patients questionnaires
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5 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Krauss E, Haberer J, Barreto G, Degen M, Seeger W, Guenther A. Recognition of breathprints of lung cancer and chronic obstructive pulmonary disease using the Aeonose(R) electronic nose. J Breath Res. 2020 Jul 24;14(4):046004. doi: 10.1088/1752-7163/ab8c50.
- Krauss E, Gehrken G, Drakopanagiotakis F, Tello S, Dartsch RC, Maurer O, Windhorst A, von der Beck D, Griese M, Seeger W, Guenther A. Clinical characteristics of patients with familial idiopathic pulmonary fibrosis (f-IPF). BMC Pulm Med. 2019 Jul 18;19(1):130. doi: 10.1186/s12890-019-0895-6.
- Witt S, Krauss E, Barbero MAN, Muller V, Bonniaud P, Vancheri C, Wells AU, Vasakova M, Pesci A, Klepetko W, Seeger W, Crestani B, Leidl R, Holle R, Schwarzkopf L, Guenther A. Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis. Respir Res. 2019 Mar 1;20(1):47. doi: 10.1186/s12931-019-1010-5.
- Loeh B, Brylski LT, von der Beck D, Seeger W, Krauss E, Bonniaud P, Crestani B, Vancheri C, Wells AU, Markart P, Breithecker A, Guenther A. Lung CT Densitometry in Idiopathic Pulmonary Fibrosis for the Prediction of Natural Course, Severity, and Mortality. Chest. 2019 May;155(5):972-981. doi: 10.1016/j.chest.2019.01.019. Epub 2019 Feb 8.
- Guenther A, Krauss E, Tello S, Wagner J, Paul B, Kuhn S, Maurer O, Heinemann S, Costabel U, Barbero MAN, Muller V, Bonniaud P, Vancheri C, Wells A, Vasakova M, Pesci A, Sofia M, Klepetko W, Seeger W, Drakopanagiotakis F, Crestani B. The European IPF registry (eurIPFreg): baseline characteristics and survival of patients with idiopathic pulmonary fibrosis. Respir Res. 2018 Jul 28;19(1):141. doi: 10.1186/s12931-018-0845-5.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EurIPFreg_150609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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