Breath Analysis by Ion Mobility Spectrometry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Lung Clinic Hemer
Sponsor:
Information provided by (Responsible Party):
Michael Westhoff MD, Lung Clinic Hemer
ClinicalTrials.gov Identifier:
NCT00632307
First received: February 29, 2008
Last updated: September 1, 2015
Last verified: August 2015
  Purpose

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.

Condition
Lung Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Lung Clinic Hemer:

Primary Outcome Measures:
  • Identification of diseases specific VOCs [ Time Frame: years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of disease specific VOCs under therapy [ Time Frame: years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

breath, pleural fluid (only in patients with therapeutic pleurocentesis)


Estimated Enrollment: 1000
Study Start Date: July 2006
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients of the lung clinic hemer with pulmonary diseases.

Criteria

Inclusion Criteria:

  • Any patient
  • Ages 18-90 years old

Exclusion criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632307

Contacts
Contact: Michael Westhoff, MD 004923729082203 michael.westhoff@lkhemer.de
Contact: Patric Litterst, MD 004923729082545 pneumologie@lkhemer.de

Locations
Germany
Lung Clinic Hemer Recruiting
Hemer, Germany, 58675
Contact: Michael Westhoff, MD    004923729082203    michael.westhoff@lkhemer.de   
Contact: Patric Litterst, MD    004923739082545    pneumologie@lkhemer.de   
Principal Investigator: Michael Westhoff, MD         
Sponsors and Collaborators
Lung Clinic Hemer
Investigators
Principal Investigator: Michael Westhoff, MD Lung Clinic Hemer, 58675 Hemer, Germany
  More Information

Publications:
Bunkowski A, Maddula S, Davies AN, Westhoff M, Litterst P, Bödeker B, Baumbach JI. One-year time series of investigations of analytes within human breath using ion mobility spectrometryInt. J. Ion Mobil. Spec. (2010) 13:141-148
Westhoff, M, Litterst P, Maddula S, Bödeker B, Rahman S, Davies AN, Baumbach JI. Differentiation of chronic obstructive pulmonary disease (COPD) including lung cancer from healthy control group by breath analysis using ion mobility spectrometry. Int. J. Ion Mobil. Spec. (2010) 13:131-139
Vautz W. Baumbach JI, Westhoff M, Züchner, K, Carstens ETH, Perl T. Breath sampling control for medical application. Int. J. Ion Mobil. Spec. (2010) 13:41-46
Westhoff, M; Litterst, P; Bödeker, B; Baumbach, J: Beath analysis by IMS for differentiation of COPD und Interstitial Lung Disease Pneumologie; 2011, 65: P278
Westhoff, M; Litterst, P; Madulla S, Bödeker, B; Baumbach, J Differentiation of COPD patients including patients with lung cancer from healthy persons by IMS. Implementation of statistic and bioinformatic methods. Pneumologie 2012; 66: V394
Westhoff M, Litterst P, Maddula S, Baumbach JI Differentiation of chronic obstructive pulmonary disease (COPD) including lung cancer from healthy control group by breath analysis using ion mobility spectrometry Eur Respir J 2011; 38: Suppl 55, P1699
Westhoff M, Litterst P, Sommer H, Bödeker B, Baumbach JI Volatile organic compounds in exhaled breath of patients with COPD ± lung cancer and their correlation with FEV1-values. Eur Respir J 2014; 44: Suppl 58, P987

Responsible Party: Michael Westhoff MD, Dr. Michael Westhoff, Lung Clinic Hemer
ClinicalTrials.gov Identifier: NCT00632307     History of Changes
Other Study ID Numbers: lkhemer1-2008
Study First Received: February 29, 2008
Last Updated: September 1, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by Lung Clinic Hemer:
lung tumor
pleural tumor
interstitial lung disease
airway infection
COPD
sleep apnea
ion mobility spectrometry
breath analysis

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 03, 2015