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Registry for Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases - EXCITING (EXCITING)

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ClinicalTrials.gov Identifier: NCT02645968
Recruitment Status : Active, not recruiting
First Posted : January 5, 2016
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
University of Giessen
German Center for Lung Research
Helmholtz Zentrum München
Institut für Lungenforschung e.V.
German Respiratory Society
WATL e.V.
Bundesverband der Pneumologen
Lungenfibrose e.V.
Sacura GmbH
Syneed Medidata GmbH
Information provided by (Responsible Party):
Michael Kreuter, Heidelberg University

Brief Summary:
The purpose of this study is to collect valid data from all forms of health care on the incidence, prevalence, the regional distribution, characteristics, management and outcomes of different ILDs under clinical practice conditions.

Condition or disease
Interstitial Lung Disease (ILD)

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry for Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases - EXCITING
Study Start Date : May 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Determination of characteristics, management and outcomes of patients with different ILDs under clinical practice conditions. [ Time Frame: Six month interval over 5 years ]
    1. (disease-related) characteristics of ILD patients
    2. diagnostic procedures for the identification of ILDs
    3. the clinical management of different (sub) types of ILD under clinical practice
    4. the outcome of different types of ILDs and of ILD related therapies from all forms of health care facilities



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ILD patients from all forms of health care
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Able to read and understand the scope and nature of data collection
  • Aged ≥ 18 at time of informed consent
  • Patients diagnosed with interstitial lung disease (ILD). Patients with suspicion on interstitial lung disease cannot be included into the registry, only after consens diagnosis of an ILD. This is also the case for patients with not classifiable ILDs.

Subjects with the following subtypes of ILD will be enrolled:

  1. Idiopathic interstitial pneumonia (IIPs)

    • Idiopathic pulmonary fibrosis (IPF)
    • Non-specific interstitial pneumonia (NSIP)
    • Desquamative interstitial pneumonia (DIP)
    • Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
    • Cryptogenic organizing pneumonia (COP)
    • Lymphocytic interstitial pneumonia (LIP)
    • Acute interstitial pneumonia (AIP)
    • Rare forms of IIPs (e.g. pleuropulmonary fibroelastosis)
    • Not classifiable IIP
  2. Granulomatous lung disease

    • Sarcoidosis
    • Berylliosis
    • Other (e.g. involvement in chronic inflammatory liver and gut diseases, except EAA)
  3. Hypersensitivity pneumonitis (exogen allergic alveolitis (EAA))

    • Farmer's lung
    • Bird keepers' lung disease
    • Origin unknown
    • Other
  4. Rheumatic and connective tissue diseases with pulmonary involvement like:

    • Connective tissue disease (subtype)
    • Vasculitis
    • Rheumatoid arthritis
  5. Pneumoconiosis

    • Asbestosis
    • Silicosis
    • Other
  6. Other forms

    • Pulmonary lymphangioleiomyomatosis
    • Pulmonary Langerhans' cell histiocytosis
    • Pulmonary alveolar proteinosis
    • Eosinophilic pneumonia
    • Post-ARDS Fibrosis
  7. Drug-related
  8. Radiotherapy associated
  9. Fibrosis in emphysema patients without signs of other ILDs (i.e. smoking related interstitial fibrosis or "emphysemasclerosis")
  10. Others
  11. Not classifiable

Furthermore for each subtype it will be queried, if a diagnosis of concomitant emphysema in ILD was made.

Exclusion Criteria:

- Patients without interstitial lung disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645968


Locations
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Germany
Lungenärztliche Gemeinschaftspraxis Dr. Storz / Dr. Prettner
Böblingen, Baden-Württemberg, Germany, 71034
Thoraxklinik Heidelberg, Abteilung Pneumologie und Beatmungsmedizin
Heidelberg, Baden-Württemberg, Germany, 69126
Gesundheitsverbund Landeskreis Konstanz, Krankenhausbetriebsgesellschaft Konstanz
Konstanz, Baden-Württemberg, Germany, 78464
Pneumologische Praxis im Zentrum - PiZ, Dr. med. Hans-Paul Eulenbruch und Dr. med. Alexander Rupp
Stuttgart, Baden-Württemberg, Germany, 70173
Klinikum Stuttgart, Klinik für Allgemeine Innere Medizin, Gastroenterologie, Hepatologie und Infektiologie, Pneumologie
Stuttgart, Baden-Württemberg, Germany, 70174
Lungenpraxis Tübingen
Tübingen, Baden-Württemberg, Germany, 72072
Pneumologisches Zentrum
Wiesloch, Baden-Württemberg, Germany, 69168
Klinikverbund Kempten-Oberallgäu, Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin
Immenstadt, Bayern, Germany, 87509
Pneumologische Gemeinschaftspraxis Fulda Dres. Wiederhold, Schratz, Wissner
Fulda, Hessen, Germany, 36039
Klinikum Fulda gAG, Medizinische Klinik V - Pneumologie
Fulda, Hessen, Germany, 36043
Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II
Giessen, Hessen, Germany, 35392
Lungenfachklinik Immenhausen
Immenhausen, Hessen, Germany, 34376
Universitätsklinikum Aachen, Medizinische Klinik I
Aachen, Nordrhein-Westfalen, Germany, 52074
Medizinisches Versorgungszentrum Malteser Bonn gem. GmbH, Malteser Lungen- und Allergiezentrum Bonn
Bonn, Nordrhein-Westfalen, Germany, 53113
Johanniter-Krankenhaus Rheinhausen GmbH
Duisburg, Nordrhein-Westfalen, Germany, 47228
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Nordrhein-Westfalen, Germany, 45239
Klinkum Gütersloh, Medizinische Klink III, Pneumologie, Schlaf- und Beatmungsmedizin, Infektiologie und Allgemeine Innere Medizin
Gütersloh, Nordrhein-Westfalen, Germany, 33332
St. Marien-Hospital GmbH
Köln, Nordrhein-Westfalen, Germany, 50668
Malteser Krankenhaus St. Hildegardis, Klinik für Pneumologie und Beatmungsmedizin
Köln, Nordrhein-Westfalen, Germany, 50931
Katholische Kranken- und Pflegeeinrichtung Leverkusen GmbH, St. Remigius Krankenhaus Opladen
Leverkusen, Nordrhein-Westfalen, Germany, 51379
framol-med GmbH, Pneumoglische Gemeinschaftspraxis Rheine
Rheine, Nordrhein-Westfalen, Germany, 48431
Krankenhaus Bethanien gGmbH, Klinik für Pneumologie und Allergologie, Zentrum für Schlaf- und Beatmungsmedizin
Solingen, Nordrhein-Westfalen, Germany, 42699
Sponsors and Collaborators
Heidelberg University
University of Giessen
German Center for Lung Research
Helmholtz Zentrum München
Institut für Lungenforschung e.V.
German Respiratory Society
WATL e.V.
Bundesverband der Pneumologen
Lungenfibrose e.V.
Sacura GmbH
Syneed Medidata GmbH
Investigators
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Principal Investigator: Michael Kreuter, Prof. Dr. Centre for interstitial and rare lung diseases, Pneumology and Respiratory Medicine, Thorax Clinic, University Hospital Heidelberg

Additional Information:

Publications:

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Responsible Party: Michael Kreuter, Head of Center for interstitial and rare lung diseases, Heidelberg University
ClinicalTrials.gov Identifier: NCT02645968     History of Changes
Other Study ID Numbers: ILD Patient Registry
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Keywords provided by Michael Kreuter, Heidelberg University:
Pneumology
Registry
EXCITING
Interstitial lung disease
ILD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases