Breath Analysis to Diagnose Lung Cancer

NCT ID: NCT03250390

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2024-04-29

Brief Summary

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

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients

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

Group Type EXPERIMENTAL

Collection of volatile organic compounds during exhalation

Intervention Type DEVICE

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)

controls

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

Group Type ACTIVE_COMPARATOR

Collection of volatile organic compounds during exhalation

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de Recherche en Informatique et en Automatique

OTHER

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role collaborator

Institut MinesTelecom (IMT)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Hulo, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)

Lille, , France

Site Status

Hôpital Calmette, CHU

Lille, , France

Site Status

Hopital Victor Provo

Roubaix, , France

Site Status

Centre Hospitalier de Saint Quentin

Saint-Quentin, , France

Site Status

Chu Amiens Salouël

Salouël, , France

Site Status

Ch Seclin - Seclin

Seclin, , France

Site Status

Clinique Teissier

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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2017-A00932-51

Identifier Type: OTHER

Identifier Source: secondary_id

PHRCI_2016

Identifier Type: OTHER

Identifier Source: secondary_id

2017_05

Identifier Type: -

Identifier Source: org_study_id

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