ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 399 studies in Lung Neoplasms with a site in France — 113 open to participants now, 149 under way, 26 of them phase 3. Lung Neoplasms · France.

Enrollment
12th of 290
1,500 · median 170
Started
2019
with 14 others
No phase
110 of 399
32 open now
Registered
180th of 399
by date

Among the 399 studies in Lung Neoplasms with a site in France, this one is the 12th largest by enrollment of the 290 interventional ones, is one of 15 that started in 2019, is one of 110 with no phase, and was the 180th registered.

By phase

399 studies; the count open now beside each. This study's row is marked.

No phasethis study110 · 32 open
Observational105 · 33 open
Phase 361 · 16 open
Phase 258 · 9 open
Phase 128 · 6 open
Phase 1/221 · 10 open
Phase 2/38 · 3 open
Phase 48 · 4 open

By the year they started

First in 1993; this study’s year is marked. 15 started in 2019.

Size and results

Median enrollment 170 across the 290 interventional studies, 190 across the 105 observational. Of the 217 that completed or were terminated, 49 (23%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 399 studies in Lung Neoplasms with a site in France, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Lung Cancer

Keywords

  • Lung cancer
  • diagnosis
  • volatile organic compounds
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with proven lung cancer

Controls:

  • healthy smoker or non-smoker subjects
  • without respiratory diseases excepted .

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

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)

06

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

07

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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Apr 2024, 60 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 60 months is above that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2017
First posted
Aug 15, 2017
StartActual
Apr 29, 2019
Primary completionActual
Apr 29, 2024
CompletionActual
Apr 29, 2024
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03250390
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 ↗

Not currently enrolling

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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Discussion

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