Lung CancerCATOCOVNCT03250390
Breath Analysis to Diagnose Lung Cancer
A study testing Collection of volatile organic compounds during exhalation in people with Lung Cancer, run by University Hospital, Lille at 7 sites in France.
Trial summary
Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Collection of volatile organic compounds during exhalation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 7 sitesFrance
- Study dates
- 29 Apr 2019to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with histologically proven lung cancer
- Controls:
- healthy smoker or non-smoker subjects
- without respiratory diseases excepted chronic obstructive pulmonary disease.
Who cannot join
- history of cancer other than lung cancer within 5 years before inclusion
- oral or facial malformation
- incomprehension of maneuvers for the collection
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)
Lille, 59000
Hôpital Calmette, CHU
Lille
Hopital Victor Provo
Roubaix
Centre Hospitalier de Saint Quentin
Saint-Quentin
Chu Amiens Salouël
Salouël
Ch Seclin - Seclin
Seclin
Clinique Teissier
Valenciennes
About this study
Official title: Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers
Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.
- Conditions
- Lung Cancer
- Being tested
- Collection of volatile organic compounds during exhalation
- Keywords
- Lung cancer, diagnosis, volatile organic compounds
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of volatile organic compounds during exhalationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patients with bronchopulmonary cancer who have not yet received therapeutic treatment. Receives: Device: Collection of volatile organic compounds during exhalation |
| controls | Active comparator | The controls consisted of 2 groups: smokers and non-smokers. Receives: Device: Collection of volatile organic compounds during exhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminating power of VOCs
Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start29 Apr 2019
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Institut Pasteur de Lille, Institut MinesTelecom (IMT)
- Responsible party
- Sponsor
- Investigators
- Sébastien Hulo, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250390
- Sponsor's protocol ID
- 2017_05
- Other IDs
- 2017-A00932-51, PHRCI_2016
- Acronym
- CATOCOV
- Status last verified
- Apr 2025
- First submitted
- 7 Aug 2017
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers
- ClinicalTrials.gov ID
- NCT03250390
- Acronym / sponsor ID
- CATOCOV / 2017_05
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, diagnosis, volatile organic compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Institut Pasteur de Lille, Institut MinesTelecom (IMT)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: Collection of volatile organic compounds during exhalationPatients with bronchopulmonary cancer who have not yet received therapeutic treatment. |
| controls | Active comparator | Device: Collection of volatile organic compounds during exhalationThe controls consisted of 2 groups: smokers and non-smokers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with histologically proven lung cancer
- healthy smoker or non-smoker subjects
- without respiratory diseases excepted chronic obstructive pulmonary disease.
Key exclusion criteria (3 listed)
- history of cancer other than lung cancer within 5 years before inclusion
- oral or facial malformation
- incomprehension of maneuvers for the collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of volatile organic compounds during exhalationThe 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) | Device | controls, patients |
Primary outcome
Discriminating power of VOCs
Time frame: 34 months
Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Hulo, MD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of volatile organic compounds during exhalation in people with Lung Cancer, run by University Hospital, Lille at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminating power of VOCs (time frame: 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.