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

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ClinicalTrials.gov Identifier: NCT03721042
Recruitment Status : Unknown
Verified October 2018 by Nouvelle Clinique Bonnefon.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
University Hospital, Montpellier
Information provided by (Responsible Party):
Nouvelle Clinique Bonnefon

Study Description
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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%.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Gastric Cancer Urologic Cancer Pneumological Cancer Device: olfactory measuring device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: exhaled air
exhaled air analysis of patients
 Device: olfactory measuring device
Patients blowing into bags then analysis by olfadiag system


Outcome Measures
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Primary Outcome Measures :
  1. positive predictive value and negative predictive value [ Time Frame: 18 months ]
    positive predictive value and negative predictive value of the electronic nose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721042


Contacts
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Contact: Adeline GIL 0033466043403 arc1@hsmed.fr

Locations
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France
Nouvelle Clinique Bonnefon
Ales, France, 34
Contact: Adeline GIL       arc1@hsmed.fr   
Sponsors and Collaborators
Nouvelle Clinique Bonnefon
University Hospital, Montpellier
More Information
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Responsible Party: Nouvelle Clinique Bonnefon
ClinicalTrials.gov Identifier: NCT03721042    
Obsolete Identifiers: NCT03715855
Other Study ID Numbers: HSM_NCB_2018-1
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urologic Neoplasms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neoplasms by Site
Neoplasms
Urogenital Neoplasms