Clinical trial NCT00632307: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases
Keywords: lung tumor
pleural tumor
interstitial lung disease
airway infection
COPD
sleep apnea
ion mobility spectrometry
breath analysis
Lead sponsor: Lung Clinic Hemer
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of the lung clinic hemer with pulmonary diseases.

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.

Eligibility criteria: Inclusion Criteria:

* Any patient
* Ages 18-90 years old

Exclusion criteria:

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

Primary outcomes:
measure: Identification of diseases specific VOCs
timeFrame: years
Secondary outcomes:
measure: Change of disease specific VOCs under therapy
timeFrame: years
Other outcomes:
Locations:
city: Hemer
country: Germany
facility: Lung Clinic Hemer
Study officials:
affiliation: Lung Clinic Hemer, 58675 Hemer, Germany
name: Michael Westhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Westhoff, M; Litterst, P; Bödeker, B; Baumbach, J: Beath analysis by IMS for differentiation of COPD und Interstitial Lung Disease Pneumologie; 2011, 65: P278
citation: 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
citation: 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
citation: 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
citation: Westhoff M, Friedrich M, Baumbach JI. Simultaneous measurement of inhaled air and exhaled breath by double multicapillary column ion-mobility spectrometry, a new method for breath analysis: results of a feasibility study. ERJ Open Res. 2022 Feb 14;8(1):00493-2021. doi: 10.1183/23120541.00493-2021. eCollection 2022 Jan.
citation: Bunkowski A, Bodeker 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 automated peak finding procedure. J Breath Res. 2009 Dec;3(4):046001. doi: 10.1088/1752-7155/3/4/046001. Epub 2009 Sep 23.
citation: Westhoff M, Litterst P, Freitag L, Urfer W, Bader S, Baumbach JI. Ion mobility spectrometry for the detection of volatile organic compounds in exhaled breath of patients with lung cancer: results of a pilot study. Thorax. 2009 Sep;64(9):744-8. doi: 10.1136/thx.2008.099465. Epub 2009 Jan 21.
citation: Westhoff M, Litterst P, Freitag L, Baumbach JI. Ion mobility spectrometry in the diagnosis of sarcoidosis: results of a feasibility study. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):739-51.
citation: 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
citation: 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
citation: 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
citation: Westhoff M, Rickermann M, Litterst P, Baumbch JI. Exogenous factors of influence on exhaled breath analysis by ion-mobility spectrometry (MCC/IMS) Int J Ion Mobil Spectr 2019, https://doi.org/10.1007/s12127-019-00247-x
citation: Westhoff, M., Rickermann, M., Franieck, E. Litterst P, Baumbach JI. Time series of indoor analytes and influence of exogeneous factors on interpretation of breath analysis using ion mobility spectrometry (MCC/IMS). Int. J. Ion Mobil. Spec. (2019) 22: 39. https://doi.org/10.1007/s12127-019-00243-1