Breath Analysis to Diagnose Lung Cancer (CATOCOV)

April 10, 2025 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
Patients with bronchopulmonary cancer who have not yet received therapeutic treatment.
Device: Collection 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)
Active Comparator: controls
The controls consisted of 2 groups: smokers and non-smokers.
Device: Collection 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Institut Pasteur de Lille
Institut National de Recherche en Informatique et en Automatique
Institut MinesTelecom (IMT)

Investigators

  • Principal Investigator: Sébastien Hulo, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2019

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_05
  • 2017-A00932-51 (Other Identifier: ID-RCB Number, ANSM)
  • PHRCI_2016 (Other Identifier: PHRC number,DGOS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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