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

Gastric Cancer Clinical Trial

— OLFADIAG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03715855
• Other study ID #: HSM_NCB_2018-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: October 2020

Study information

• Verified date: October 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Gastric Cancer
• Pneumological Cancer
• Stomach Neoplasms
• Urologic Cancer
• Urologic Neoplasms

Intervention

Device:
• olfactory measuring device
Patients blowing into bags then analysis by olfadiag system Patients blowing into sachets then analysis by olfadiag system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value and negative predictive value	positive predictive value and negative predictive value of the electronic nose	18 months