Mass Spectral Fingerprinting in Lung Cancer

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT02781857

Collaborator

Swiss Federal Institute of Technology (Other)

160

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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).	Other: No intervention
60 controls 60 controls (group C) matched for age, gender, smoking history.	Other: No intervention

Arm

Intervention/Treatment

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).

Other: No intervention

60 controls

60 controls (group C) matched for age, gender, smoking history.

Other: No intervention

Outcome Measures

Primary Outcome Measures

Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry [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).

Secondary Outcome Measures

Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery [Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement]
The acquired profiles of mass spectral VOCs before and after lung cancer surgery will be analysed for significant differences.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Division of Pneumology	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

University of Zurich
Swiss Federal Institute of Technology

Investigators

Principal Investigator: Malcolm Kohler, Prof. MD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT02781857

Other Study ID Numbers:

KEK-ZH-Nr.2015-0607

First Posted:

May 25, 2016

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Keywords provided by University of Zurich

Exhaled Breath

Mass Spectrometry

Fingerprinting

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Jan 26, 2022