Trial document




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  DRKS00000314

Trial Description

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Title

Clinical investigation of biomarkers in exhaled breath with ion mobility spectrometry (IMS) and differential mobility spectrometry (DMS)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is the evaluation of a new diagnostic method to measure biomarkers in exhaled breath in different lung diseases. We will test, if this diseases could be diagnosed more rapidly and easily with this method. Moreover, we want to verify if it is possible to control a therapy in measuring this biomarkers.

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Brief Summary in Scientific Language

The subject of this study is to detect volatile organic compunds (VOC) in exhaled breath and assign this patterns to dedicated lung diseases. This non-invasive method may substitute some more invasive diagnostic procedures. In diseases who require a microbiologic or histopathologic finding, a more rapid diagnosis may be obtained. Finally, we want to verify if it is possible to control a therapy in measuring this biomarkers in exhaled breath.

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Organizational Data

  •   DRKS00000314
  •   2010/01/25
  •   [---]*
  •   yes
  •   Approved
  •   09-4256, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1113-4754 
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Health Condition or Problem studied

  •   C34.0 -  Malignant neoplasm: Main bronchus
  •   J44 -  Other chronic obstructive pulmonary disease
  •   E84.0 -  Cystic fibrosis with pulmonary manifestations
  •   J84 -  Other interstitial pulmonary diseases
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Interventions/Observational Groups

  •   Measurement of volatile organic compunds in exhaled breath
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

discriminant analysis of volatile organic compunds in different lung diseases measured with ion mobility spectroscopy

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/18
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1.) written Informed consent
2.) clinical, radiological or anamnestic findings in conformity with a malign lung tumor, cystic fibrosis, interstitial or infectious lung disease and patients listed for or after lung transplantation

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Exclusion Criteria

not existent

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Addresses

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    • Kooperation der Abteilung für interventionelle Pneumologie (Chefarzt PD Lutz Freitag) und der Abteilung Pneumologie-Universitätsklinik (Chefarzt Prof. Helmut Teschler) des Westdeutsches Lungenzentrum am Universitätsklinikum
    • Mr.  Dr. med.  Lutz  Freitag 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Abteilung für interventionelle Pneumologie Westdeutsches Lungenzentrum am Universitätsklinikum
    • Mr.  Dr. med.  Kaid  Darwiche 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik - Uniklinikum Essen Westdeutsches Lungenzentrum Abt. für interventionelle Pneumologie
    • Mr.  Dr. med.  Kaid  Darwiche 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • B&S Analytik GmbH BioMedizinZentrum Dortmund
    • Mr.  Dr. med.  Jörg-Ingo  Baumbach 
    • Otto-Hahn-Str. 15
    • 44227  Dortmund
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.