Mass Spectral Fingerprinting in Lung Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 100 patients with lung cancer<br>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<br> <br> |
| 60 controls<br>60 controls (group C) matched for age, gender, smoking history. | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fingerprinting, Exhaled Breath, Mass Spectrometry