Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples (OLFADIAG)

Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples

The investigators don't know yet how the nose and the brain decode the smells. Scientific studies in neuroscience have shown that people who have tumors may have changes in the smell of secretions. Dogs are extremely efficient at detecting these changes, even before imaging studies. A review of the recent literature shows the different work done on the diagnosis of dogs on human pathologies, especially oncology. It is now known that the smell of exhaled gases is representative of the intestinal biotope and that a large number of pathologies are related to the type of microbial populations that inhabit the intestines.

Copying the olfactory organs could thus be of major interest for the early diagnosis of pathologies. More and more works are interested in the diagnostic power of electronic noses. From a technical point of view, these are nano-sensors that mimic the olfactory receptors from the breath gas of the subjects. They analyze the molecules present and compare them with a database to establish a diagnosis according to a probabilistic algorithm.

The use of exhaled air for the diagnosis of cancerous pathologies has already been the subject of scientific work. A classification using the SVM (support vector machine) method using data from 320 sensors made it possible to differentiate patients with lung cancer from controls in 98.8% of cases. The differential diagnosis of obstructive bronchopneumopathy was also very well done in this same study. Another study shows equally encouraging results, highlighting sensitivities and specificities above 80%.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer; Alzheimer Disease; Urologic Cancer; Pneumological Cancer
• Intervention / Treatment: Device: olfactory measuring device

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ales, France, 34
    • Nouvelle Clinique BONNEFON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient must have signed the free and informed consent form or their guardian if applicable. If the state of health of the patient does not allow him to give and sign his consent, it will be sought from the person of trust
• The patient must be an affiliate or beneficiary of a health insurance plan
• The patient is at least 18 years old

Exclusion Criteria:

• The patient participates or has participated within 3 months in another study that may have modified their intestinal biotope
• The patient is in an exclusion period determined by a previous study
• The patient is under the protection of justice
• The patient or guardian or trusted person refuses to sign the consent
• The patient does not read the French language fluently
• The patient claims to be pregnant
• The patient is breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exhaled air; exhaled air analysis of patients	Device: olfactory measuring device; Patients blowing into bags then analysis by olfadiag system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive predictive value and negative predictive value	positive predictive value and negative predictive value of the electronic nose	18 months

Collaborators and Investigators

• Sponsor: Nouvelle Clinique Bonnefon
• Collaborators: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Urologic Neoplasms
• Other Study ID Numbers: HSM_NCB_2018-1

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