NCT00632307

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

17.5 years

First QC Date

February 29, 2008

Last Update Submit

August 21, 2022

Conditions

Lung Diseases

Keywords

lung tumorpleural tumorinterstitial lung diseaseairway infectionCOPDsleep apneaion mobility spectrometrybreath analysis

Outcome Measures

Primary Outcomes (1)

  • Identification of diseases specific VOCs

    years

Secondary Outcomes (1)

  • Change of disease specific VOCs under therapy

    years

Study Arms (8)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of the lung clinic hemer with pulmonary diseases.

You may qualify if:

  • Any patient
  • Ages 18-90 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lung Clinic Hemer

Hemer, 58675, Germany

RECRUITING

Related Publications (13)

  • Westhoff, M; Litterst, P; Bödeker, B; Baumbach, J: Beath analysis by IMS for differentiation of COPD und Interstitial Lung Disease Pneumologie; 2011, 65: P278

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 35174246BACKGROUND

  • 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.

    PMID: 21386194RESULT

  • 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.

    PMID: 19158121RESULT

  • 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.

    PMID: 18204189RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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

    RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Lung DiseasesLung NeoplasmsPleural NeoplasmsLung Diseases, InterstitialPulmonary Disease, Chronic ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Michael Westhoff, MD

    Lung Clinic Hemer, 58675 Hemer, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Westhoff, MD

CONTACT

004923729082203michael.westhoff@lkhemer.de

Patric Litterst, MD

CONTACT

004923729082545pneumologie@lkhemer.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Michael Westhoff

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 10, 2008

Study Start

July 1, 2006

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations

DE(1)