NCT02781857

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
393

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

8.3 years

First QC Date

April 26, 2016

Last Update Submit

March 17, 2025

Conditions

Lung Cancer

Keywords

Exhaled BreathMass SpectrometryFingerprinting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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

    Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement

Study Arms (2)

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

Interventions

No interventionOTHER
100 patients with lung cancer60 controls

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with lung cancer will be included according to the predefined inclusion and exclusion criteria. Matched controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Herth J, Schmidt F, Basler S, Sievi NA, Kohler M. Exhaled breath analysis in patients with potentially curative lung cancer undergoing surgery: a longitudinal study. J Breath Res. 2024 May 17;18(3). doi: 10.1088/1752-7163/ad48a9.

    PMID: 38718786DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Malcolm Kohler, Prof. MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 25, 2016

Study Start

May 1, 2016

Primary Completion

July 31, 2024

Study Completion

March 31, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)