Clinical trial NCT03721042: Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples
Official title: Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Gastric Cancer
Urologic Cancer
Pneumological Cancer
Lead sponsor: Nouvelle Clinique Bonnefon
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
First posted: 2018-10-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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%.


Eligibility criteria: 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

Primary outcomes:
measure: positive predictive value and negative predictive value
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ales
country: France
facility: Nouvelle Clinique Bonnefon
Study officials:
References: