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

NCT03721042 | Terminated

• 1 other identifier: HSM_NCB_2018-1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Alzheimer Disease; Gastric Cancer; Urologic Cancer; Pneumological Cancer

Outcome Measures

Primary Outcomes (1)

• positive predictive value and negative predictive value

  positive predictive value and negative predictive value of the electronic nose

  18 months

Study Arms (1)

exhaled air

EXPERIMENTAL

exhaled air analysis of patients

Device: olfactory measuring device

Interventions

olfactory measuring device DEVICE

Patients blowing into bags then analysis by olfadiag system

exhaled air

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient participates or has participated within 3 months in another study that may have modified their intestinal biotope
• 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

Sponsors & Collaborators

• Nouvelle Clinique Bonnefon: lead
• University Hospital, Montpellier: collaborator

Study Sites (1)

Nouvelle Clinique Bonnefon

Alès, 34, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Stomach Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: October 11, 2018
• Primary Completion: November 5, 2019
• Study Completion: October 1, 2020
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)