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Breath Analysis to Diagnose Lung Cancer (CATOCOV)

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of volatile organic compounds during exhalation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, diagnosis, volatile organic compounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)Recruiting
  • Hôpital Calmette, CHURecruiting
  • Hopital Victor ProvoRecruiting
  • Centre Hospitalier de Saint QuentinRecruiting
  • Chu Amiens SalouëlRecruiting
  • Ch Seclin - SeclinRecruiting
  • Clinique TeissierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients

controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2017
Last Updated
November 7, 2022
Sponsor
University Hospital, Lille
Collaborators
Institut National de Recherche en Informatique et en Automatique, Institut Pasteur de Lille, Institut MinesTelecom (IMT)
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1. Study Identification

Unique Protocol Identification Number
NCT03250390
Brief Title
Breath Analysis to Diagnose Lung Cancer
Acronym
CATOCOV
Official Title
Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
April 29, 2023 (Anticipated)
Study Completion Date
April 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Institut National de Recherche en Informatique et en Automatique, Institut Pasteur de Lille, Institut MinesTelecom (IMT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, diagnosis, volatile organic compounds

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
Patients with bronchopulmonary cancer who have not yet received therapeutic treatment.
Arm Title
controls
Arm Type
Active Comparator
Arm Description
The controls consisted of 2 groups: smokers and non-smokers.
Intervention Type
Device
Intervention Name(s)
Collection of volatile organic compounds during exhalation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Discriminating power of VOCs
Description
Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.
Time Frame
34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Hulo, MD
Phone
3.20.44.52.85
Ext
+33
Email
sebastien.hulo@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Hulo, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Calmette, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hulo Sébastien, MD
Facility Name
Hopital Victor Provo
City
Roubaix
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Saint Quentin
City
Saint-Quentin
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Amiens Salouël
City
Salouël
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Seclin - Seclin
City
Seclin
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrielle Jardin, MD
Facility Name
Clinique Teissier
City
Valenciennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas GEY, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Breath Analysis to Diagnose Lung Cancer

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