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Clinical Trial Finder

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

Study Purpose

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/).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Informed consent signed.

Exclusion Criteria:

- No informed consent signed

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02951416
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Andreas Guenther
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries Austria, France, Germany, Italy, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonia, Interstitial Lung Diseases, Diffuse Parenchymal Lung Diseases
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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).

: Non-specific interstitial pneumonia

Non-specific interstitial pneumonia (NSIP) based on the histopathological demonstration of an NSIP pattern. Patient registry (observation and biomaterial sampling).

: 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).

: 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).

: 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).

: respiratory bronchiolitis-ILD (RB-ILD)

Histological pattern of RB-ILD or typical clinical and radiological findings. Patient registry (observation and biomaterial sampling).

: 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).

: 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).

: Sarcoidosis

Histological pattern with sarcoid granulomas or typical clinical and radiological findings with a lymphocytosis in BAL. Patient registry (observation and biomaterial sampling).

: Lung Cancer

Histological confirmation of Lung Cancer. Patients will be included as control group. Patient registry (observation and biomaterial sampling).

: 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).

: Pulmonary Hypertension

Pulmonary Hypertension (PH) diagnosed through right heart catheterisation. Patients will be included as control group. Patient registry (observation and biomaterial sampling).

: Sleep Apnea

Sleep Apnea diagnosed by polysomnography. Patients will be included as control group. Patient registry (observation and biomaterial sampling).

: 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).

: Control/Health Individuals

Healthy volunteers not suffering from any lung disease as control group. Patient registry (observation and biomaterial sampling).

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Medizinische Universität Wien, Vienna, Austria

Status

Address

Medizinische Universität Wien

Vienna, ,

Centre Hospitalier Universitaire Dijon, Dijon, France

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Centre Hospitalier Universitaire Dijon

Dijon, ,

Hopital Bichat Paris, Paris, France

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Address

Hopital Bichat Paris

Paris, ,

Andreas Guenther, Giessen, Germany

Status

Address

Andreas Guenther

Giessen, , 35392

Lungenfachklinik Waldhof Elgershausen, Greifenstein, Germany

Status

Address

Lungenfachklinik Waldhof Elgershausen

Greifenstein, ,

Università degli Studi di Catania, Catania, Italy

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Address

Università degli Studi di Catania

Catania, ,

Royal Brompton Hospital, London, United Kingdom

Status

Address

Royal Brompton Hospital

London, ,

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