Breath Analysis by Ion Mobility Spectrometry

• Sponsor: Lung Clinic Hemer (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00632307
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Duration (Months): 210
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Other
• 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
• Study Start Date: Jul 1, 2006
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Identification of diseases specific VOCs [years]

Secondary Outcome Measures

1. Change of disease specific VOCs under therapy [years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any patient

• Ages 18-90 years old

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lung Clinic Hemer	Hemer		Germany	58675

Sponsors and Collaborators

• Lung Clinic Hemer

Investigators

• Principal Investigator: Michael Westhoff, MD, Lung Clinic Hemer, 58675 Hemer, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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). pii: 00493-2021. doi: 10.1183/23120541.00493-2021. eCollection 2022 Jan.
• 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
• 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

• Responsible Party: Michael Westhoff MD, Dr. Michael Westhoff, Lung Clinic Hemer
• ClinicalTrials.gov Identifier: NCT00632307
• Other Study ID Numbers: lkhemer1-2008
• First Posted: Mar 10, 2008
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by Michael Westhoff MD, Dr. Michael Westhoff, 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

Study Results

No Results Posted as of Aug 24, 2022