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Breath Analysis by Ion Mobility Spectrometry

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ClinicalTrials.gov Identifier: NCT00632307
Recruitment Status : Recruiting
First Posted : March 10, 2008
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Westhoff MD, Lung Clinic Hemer

Tracking Information
First Submitted Date February 29, 2008
First Posted Date March 10, 2008
Last Update Posted Date September 2, 2020
Study Start Date July 2006
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2015)
Identification of diseases specific VOCs [ Time Frame: years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: September 1, 2015)
Change of disease specific VOCs under therapy [ Time Frame: years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breath Analysis by Ion Mobility Spectrometry
Official Title Detection of Clusters of Volatile Organic Compounds (VOC)in Patients With Different Lung Disorders by Ion Mobility Spectrometry. Different Clusters of VOC in the Diagnosis of Different Lung Disorders Using Ion Mobility Spectrometry
Brief Summary

Recognition of disease specific clusters of volatile organic compounds in patients with different lung diseases, using breath analysis with ion mobility spectrometry. Lung diseases of interest are:

  • COPD
  • tumors
  • airway infection
  • interstitial lung disease
  • sleep apnea Hypothesis: Breath analysis with ion mobility spectrometry can differentiate pulmonary disorders.
Detailed Description Recruitment of patients with different lung diseases goes on. First sub-group analysis of patients with COPD,lung cancer and sarcoidosis is done in order to create a training set of VOC-clusters for further validation in a bigger population of patients.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
breath, pleural fluid (only in patients with therapeutic pleurocentesis)
Sampling Method Non-Probability Sample
Study Population patients of the lung clinic hemer with pulmonary diseases.
Condition Lung Diseases
Intervention Not Provided
Study Groups/Cohorts
  • 1
    COPD
  • 2
    lung cancer
  • 3
    airway infection
  • 4
    interstitial lung disease
  • 5
    sleep apnea
  • 6
    pulmonary disorders with pleural infusions
  • 7
    sarcoidosis
  • 8
    healthy persons
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2011)
1000
Original Estimated Enrollment
 (submitted: March 7, 2008)
250
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any patient
  • Ages 18-90 years old

Exclusion criteria:

- Patient who are not able to perform an exhalation manoever.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Michael Westhoff, MD 004923729082203 michael.westhoff@lkhemer.de
Contact: Patric Litterst, MD 004923729082545 pneumologie@lkhemer.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00632307
Other Study ID Numbers lkhemer1-2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Westhoff MD, Lung Clinic Hemer
Study Sponsor Lung Clinic Hemer
Collaborators Not Provided
Investigators
Principal Investigator: Michael Westhoff, MD Lung Clinic Hemer, 58675 Hemer, Germany
PRS Account Lung Clinic Hemer
Verification Date August 2020