Lung CancerNCT02781857
Mass Spectral Fingerprinting in Lung Cancer
An observational study of Lung Cancer, run by University of Zurich at 1 site in Switzerland.
Trial summary
To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer
- How many people
- 309 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to 6 Mar 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung cancer will be included according to the predefined inclusion and exclusion criteria. Matched controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
Who may be able to join
- Confirmed lung cancer based on cytological or histological analysis.
- Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
- Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
- Group C: matched controls.
- Age between 18 and 85 years at study entry
Who cannot join
- Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
- Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- Any other acute lung disease which affects breath measurements
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091
About this study
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer
To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
- Conditions
- Lung Cancer
- Being tested
- No intervention
- Keywords
- Exhaled Breath, Mass Spectrometry, Fingerprinting
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 100 patients with lung cancer | * Group A: 70 patients with any type of lung cancer eligible for lung cancer surgery
* Group B: 30 patients with any type of lung cancer not eligible to surgery (small-cell carcinoma, squamous cell carcinoma, adenocarcinoma, large-cell carcinoma). Receives: Other: No intervention | |
| 60 controls | 60 controls (group C) matched for age, gender, smoking history. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
The primary outcome will be the lung cancer specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of lung cancer in exhaled breath).
Measured: 1 day, single measurement
Secondary outcomes (1)
Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery
The acquired profiles of mass spectral VOCs before and after lung cancer surgery will be analysed for significant differences.
Measured: Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startMay 2016
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781857
- Sponsor's protocol ID
- KEK-ZH-Nr.2015-0607
- Status last verified
- May 2026
- First submitted
- 26 Apr 2016
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: upon reasonable request only
Publications
Fricke K, Herth J, Baur DM, Sievi NA, Schmidt F, Gaisl T, Steinack C, Ulrich S, Kohler M. Real-time breath metabolomic profiling reveals a volatile signature associated with lung cancer. Biomed Pharmacother. 2026 Aug 6;202:119835. doi: 10.1016/j.biopha.2026.119835. Online ahead of print.
PubMed 42561601Herth J, Schmidt F, Basler S, Sievi NA, Kohler M. Exhaled breath analysis in patients with potentially curative lung cancer undergoing surgery: a longitudinal study. J Breath Res. 2024 May 17;18(3). doi: 10.1088/1752-7163/ad48a9.
PubMed 38718786
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT02781857
- Acronym / sponsor ID
- KEK-ZH-Nr.2015-0607
- Conditions
- Lung Cancer
- Keywords
- Exhaled Breath, Mass Spectrometry, Fingerprinting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- May 2016 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 25 May 2016 (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.
To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients with lung cancer | – | Other: No intervention* Group A: 70 patients with any type of lung cancer eligible for lung cancer surgery * Group B: 30 patients with any type of lung cancer not eligible to surgery (small-cell carcinoma, squamous cell carcinoma, adenocarcinoma, large-cell carcinoma). |
| 60 controls | – | Other: No intervention60 controls (group C) matched for age, gender, smoking history. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer will be included according to the predefined inclusion and exclusion criteria. Matched controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
Key inclusion criteria (5 listed)
- Confirmed lung cancer based on cytological or histological analysis.
- Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
- Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
- Group C: matched controls.
- Age between 18 and 85 years at study entry
Key exclusion criteria (5 listed)
- Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
- Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- Any other acute lung disease which affects breath measurements
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | 100 patients with lung cancer, 60 controls |
Primary outcome
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
Time frame: 1 day, single measurement
The primary outcome will be the lung cancer specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of lung cancer in exhaled breath).
1 secondary outcome
Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery
Time frame: Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 42561601Fricke K, Herth J, Baur DM, Sievi NA, Schmidt F, Gaisl T, Steinack C, Ulrich S, Kohler M. Real-time breath metabolomic profiling reveals a volatile signature associated with lung cancer. Biomed Pharmacother. 2026 Aug 6;202:119835. doi: 10.1016/j.biopha.2026.119835. Online ahead of print.
- Derived from this study: PubMed 38718786Herth J, Schmidt F, Basler S, Sievi NA, Kohler M. Exhaled breath analysis in patients with potentially curative lung cancer undergoing surgery: a longitudinal study. J Breath Res. 2024 May 17;18(3). doi: 10.1088/1752-7163/ad48a9.
- Individual participant dataSharing planned: No. upon reasonable request only
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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.
Malcolm Kohler, Prof. MD principal investigator
University of Zurich
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 Cancer, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Jun 2026. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry (time frame: 1 day, single measurement). 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 NCT02781857, which also lists 2 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 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.