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CompletedNCT03250390CATOCOVUpdated Apr 15, 2025

Breath Analysis to Diagnose Lung Cancer

An interventional study of Collection of volatile organic compounds during exhalation in Lung Cancer, sponsored by University Hospital, Lille. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung cancer
  • diagnosis
  • volatile organic compounds
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with histologically proven lung cancer

Controls:

  • healthy smoker or non-smoker subjects
  • without respiratory diseases excepted chronic obstructive pulmonary disease.

Exclusion criteria

Exclusion Criteria:

  • history of cancer other than lung cancer within 5 years before inclusion
  • oral or facial malformation
  • incomprehension of maneuvers for the collection
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,500 participants (actual)

Study arms

  • Experimental
    patients

    Patients with bronchopulmonary cancer who have not yet received therapeutic treatment.

    Device: Collection of volatile organic compounds during exhalation

  • Active comparator
    controls

    The controls consisted of 2 groups: smokers and non-smokers.

    Device: Collection of volatile organic compounds during exhalation

Interventions

  • DeviceCollection of volatile organic compounds during exhalation

    The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler. The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)

05

What researchers measure

Primary outcomes

  1. Discriminating power of VOCs

    Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.

    Time frame: 34 months

06

Study locations

7 sites
  • Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)
    Lille, 59000, France
  • Hôpital Calmette, CHU
    Lille, France
  • Hopital Victor Provo
    Roubaix, France
  • Centre Hospitalier de Saint Quentin
    Saint-Quentin, France
  • Chu Amiens Salouël
    Salouël, France
  • Ch Seclin - Seclin
    Seclin, France
  • Clinique Teissier
    Valenciennes, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03250390
Lead sponsor
University Hospital, Lille
Collaborators
Institut National de Recherche en Informatique et en Automatique, Institut Pasteur de Lille, Institut MinesTelecom (IMT)
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Apr 29, 2019
Primary completion
Apr 29, 2024
Completion
Apr 29, 2024
Last update
Apr 15, 2025

Study contacts

Sébastien Hulo, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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