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JOURNAL ONKOLOGIE – STUDIE

Mass Spectral Fingerprinting in Lung Cancer

Rekrutierend

NCT-Nummer:
NCT02781857

Studienbeginn:
Mai 2016

Letztes Update:
11.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
Swiss Federal Institute of Technology

Studienleiter

Malcolm Kohler, Prof. MD
Principal Investigator
University of Zurich

Kontakt

Studienlocations
(1 von 1)

University Hospital Zurich, Division of Pneumology
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Malcolm Kohler, Prof. MD
Phone: +41 44 255 38 28
E-Mail: malcolm.kohler@usz.ch

Felix Schmidt, Rph
Phone: +41442554801
E-Mail: felix.schmidt@usz.ch
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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).



Secondary outcome:

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 (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):
The acquired profiles of mass spectral VOCs before and after lung cancer surgery will be analysed for significant differences.

Studien-Arme

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

Geprüfte Regime

  • No intervention

Quelle: ClinicalTrials.gov


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