Lung DiseasesNCT00632307
Breath Analysis by Ion Mobility Spectrometry
An observational study of Lung Diseases, run by Lung Clinic Hemer at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients of the lung clinic hemer with pulmonary diseases.
Who may be able to join
- Any patient
- Ages 18-90 years old
Who cannot join
- Patient who are not able to perform an exhalation manoever.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Lung Clinic Hemer
Hemer, 58675
Michael Westhoff, MD, 004923729082203, michael.westhoff@lkhemer.de
Patric Litterst, MD, 004923739082545, pneumologie@lkhemer.de
About this study
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
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.
Read the 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.
- Conditions
- Lung Diseases
- Keywords
- lung tumor, pleural tumor, interstitial lung disease, airway infection, COPD, sleep apnea, ion mobility spectrometry, breath analysis
- Medical subject headings
- Lung Diseases, Lung Neoplasms, Pleural Neoplasms, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of diseases specific VOCs
Measured: years
Secondary outcomes (1)
Change of disease specific VOCs under therapy
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startJul 2006
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lung Clinic Hemer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Westhoff MD, Lung Clinic Hemer
- Investigators
- Michael Westhoff, MD, Principal investigator, Lung Clinic Hemer, 58675 Hemer, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632307
- Sponsor's protocol ID
- lkhemer1-2008
- Status last verified
- Aug 2022
- First submitted
- 29 Feb 2008
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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
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.
PubMed 35174246Bunkowski 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.
PubMed 21386194Westhoff 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.
PubMed 19158121Westhoff 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.
PubMed 18204189Bunkowski 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, 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00632307
- Acronym / sponsor ID
- lkhemer1-2008
- Conditions
- Lung Diseases
- Keywords
- lung tumor, pleural tumor, interstitial lung disease, airway infection, COPD, sleep apnea, ion mobility spectrometry, breath analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lung Clinic HemerUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients of the lung clinic hemer with pulmonary diseases.
Key inclusion criteria (2 listed)
- Any patient
- Ages 18-90 years old
Key exclusion criteria (1 listed)
- Patient who are not able to perform an exhalation manoever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of diseases specific VOCs
Time frame: years
1 secondary outcome
Change of disease specific VOCs under therapy
Time frame: years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- BackgroundWesthoff, M; Litterst, P; Bödeker, B; Baumbach, J: Beath analysis by IMS for differentiation of COPD und Interstitial Lung Disease Pneumologie; 2011, 65: P278
- BackgroundWesthoff, 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
- BackgroundWesthoff 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
- BackgroundWesthoff 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
- Background: PubMed 35174246Westhoff 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.
- Results publication: PubMed 21386194Bunkowski 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.
- Results publication: PubMed 19158121Westhoff 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.
- Results publication: PubMed 18204189Westhoff 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.
- Results publicationBunkowski 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
- Results publicationWesthoff, 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
- Results publicationVautz 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
- Results publicationWesthoff 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Westhoff, MD principal investigator
Lung Clinic Hemer, 58675 Hemer, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Lung Clinic Hemer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Westhoff, MD (004923729082203, michael.westhoff@lkhemer.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of diseases specific VOCs (time frame: years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632307, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.