Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000026

Trial Description

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Title

Examination of expired air for volatile organic substances by means of ionic mobility spectrometry

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Analysis of exhaled breath for volatile organic compounds (VOC) with ion mobility spectrometry in different pulmonary disorders with the intention to find disciriminating combinations of VOCs or VOCs that give information about diseases activity. For this patients shall have breath analysis before and after therapies.

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Brief Summary in Scientific Language

Breath analysis with ion mobility spectrometry to find clusters of volatile oragnic compounds which are diagnostic or give information about disease activity.
Comparison of breath analysis with head space analysis of pleural effusion in patients with scheduled pleural scentesis.

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Organizational Data

  •   DRKS00000026
  •   2008/09/05
  •   2008/02/25
  •   no
  •   Approved
  •   2007-402-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1113-3230 
  •   NCT00632307  (Clinicaltrials.gov)
  •   UKF001453  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   Analysis of exhaled breath
  •   J90 -  Pleural effusion, not elsewhere classified
  •   J91 -  Pleural effusion in conditions classified elsewhere
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Interventions/Observational Groups

  •   Analysis of exhaled breath (in patients without pulmonary disorders)
  •   Analysis of exhaled breath (in patients with different pulmonary disorders) and analysis of VOCs
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

End point is reached when a discriminating VOC cluster is found for each disorder.

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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
  •   2007/11/01
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

All patients from 18 - 90 years

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Exclusion Criteria

age < 18 and > 90 years
inability to cooperate for the exhalation procedure

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Addresses

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    • Lungenklinik Hemer, Klinik für Pneumologie, Beatmungs- und Schlafmedizin
    • Mr.  Dr. med.  Michael  Westhoff 
    • Theo-Funccius-Str. 1
    • 58675  Hemer
    • Germany
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    • Lungenklinik Hemer Klinik für Pneumologie
    • Mr.  Dr. med.  Michael  Westhoff 
    • Theo-Funccius-Str. 1
    • 58675  Hemer
    • Germany
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    • Lungenklinik Hemer Klinik für Pneumologie
    • Mr.  Dr. med.  Michael  Westhoff 
    • Hemer
    • Germany
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    •   02372-9082201
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • ISAS - Institute for Analytical Sciences
    • Mr.  Dr.  Jörg Ingo  Baumbach 
    • Bunsen-Kirchhoff-Str. 11
    • 44139  Dortmund
    • Germany
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Status

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

  •   Ruzsanyi V, Baumbach JI, Sielemann S, Litterst P, Westhoff M, Freitag L
    Detection of human metabolites using multi-capillary columns coupled to ion mobility spectrometers.
    J Chromatogr A. 2005 Aug 19;1084(1-2):145-51.

    Westhoff M, Freitag L, Litterst P, Ruzsany V, Bader S, Urfer W, Baumbach JI
    Ion mobility spectrometry: A new method for the detection of lung cancer and airway infection in exhaled air?
    First results of a pilot study.
    Chest 2005; 128: S 155
    Litterst P, Westhoff M, Freitag L, Ruzsany V, Baumbach JI
    Bacterial differentiation by ion mobility spectrometry: First results of a pilot study.
    Chest 2005; 128: S 375
    Westhoff M, Litterst P, Freitag L, Ruzsany V, Bader S, Urfer W, Baumbach JI
    Ionenmobilitätsspektrometrie ? eine neue Methode zur Detektion von Bronchialkarzinomen und Atemwegsinfektionen in der Ausatemluft? ? Erste Resultate einer Pilotstudie.
    Pneumologie 2006; 60: S 81
    Westhoff M, Litterst P, Freitag L, Obertrifter B, Ruzsanyi V, Baumbach JI
    Ion mobility spectrometry ? a new method in the diagnostic approach
    to sarcoidosis? ? Preliminary data.
    Eur Respir J 2006; 28: 111 S

    Baumbach JI, Westhoff M
    Ion mobility spectrometry to detect lung cancer and airway infections
    Spectrosc. Europe 2006; 18: 22 - 27
    Westhoff M, Litterst P, Freitag L, Baumbach JI.
    Ion mobility spectrometry in the diagnosis of sarcoidosis: results of a feasbility study.
    J Physiol Pharmacol. 2007;58 Suppl 5:739 - 751
    Westhoff M, Litterst P, Obertrifter B, Bunkowski A, Baumbach JI
    Breath analysis by ion mobility spectrometry in sarcoidosis: results of a feasability study.
    Eur Respir J 2008; 32: 258 s
    Westhoff M, Litterst P, Freitag P, Ruzsanyi P, Baumbach JI
    Ion moblitiy spectrometry for the detection of VOC?s in patients with lung cancer.
    Results of a pilot study.
    Thorax 2009; 64: 744 - 748

    Bunkowski A, Bödeker B, Bader S, Westhoff M, Litterst P, Baumbach JI
    MCC / IMS signals in human breath related to sarcoidosis ? results of a feasibility study using
    an automatic peak finding procedure.
    J Breath Res 2009; 3: 046001
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* This entry means the parameter is not applicable or has not been set.