NCT03250390

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

August 7, 2017

Last Update Submit

April 10, 2025

Conditions

Keywords

Lung cancerdiagnosisvolatile organic compounds

Outcome Measures

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.

    34 months

Study Arms (2)

patients

EXPERIMENTAL

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

Device: Collection of volatile organic compounds during exhalation

controls

ACTIVE COMPARATOR

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

Device: Collection of volatile organic compounds during exhalation

Interventions

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)

controlspatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with histologically proven lung cancer
  • Controls:
  • healthy smoker or non-smoker subjects
  • without respiratory diseases excepted chronic obstructive pulmonary disease.

You may not qualify if:

  • oral or facial malformation
  • incomprehension of maneuvers for the collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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

Lille, 59000, France

Location

Hôpital Calmette, CHU

Lille, France

Location

Hopital Victor Provo

Roubaix, France

Location

Centre Hospitalier de Saint Quentin

Saint-Quentin, France

Location

Chu Amiens Salouël

Salouël, France

Location

Ch Seclin - Seclin

Seclin, France

Location

Clinique Teissier

Valenciennes, France

Location

MeSH Terms

Conditions

Lung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sébastien Hulo, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 15, 2017

Study Start

April 29, 2019

Primary Completion

April 29, 2024

Study Completion

April 29, 2024

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations