Mass Spectral Fingerprinting in Lung Cancer

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02781857
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-26
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Primary Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 393

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
100 patients with lung cancer	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	No intervention	60 controls (group C) matched for age, gender, smoking history.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zurich, ZH, Switzerland