Mass Spectral Fingerprinting in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781857
• Other study ID #: KEK-ZH-Nr.2015-0607
• Status: Recruiting
• Start date: May 2016
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: Malcolm Kohler, Prof. MD
• Phone: +41 44 255 38 28
• Email: malcolm.kohler[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day, single measurement
Secondary	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.	Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement