Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples (OLFADIAG)
Primary Purpose
Alzheimer Disease, Gastric Cancer, Urologic Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactory measuring device
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease
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
Sites / Locations
- Nouvelle Clinique Bonnefon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exhaled air
Arm Description
exhaled air analysis of patients
Outcomes
Primary Outcome Measures
positive predictive value and negative predictive value
positive predictive value and negative predictive value of the electronic nose
Secondary Outcome Measures
Full Information
NCT ID
NCT03721042
First Posted
October 25, 2018
Last Updated
April 7, 2022
Sponsor
Nouvelle Clinique Bonnefon
Collaborators
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03721042
Brief Title
Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples
Acronym
OLFADIAG
Official Title
Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
no PI to continue the study
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nouvelle Clinique Bonnefon
Collaborators
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Gastric Cancer, Urologic Cancer, Pneumological Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exhaled air
Arm Type
Experimental
Arm Description
exhaled air analysis of patients
Intervention Type
Device
Intervention Name(s)
olfactory measuring device
Intervention Description
Patients blowing into bags then analysis by olfadiag system
Primary Outcome Measure Information:
Title
positive predictive value and negative predictive value
Description
positive predictive value and negative predictive value of the electronic nose
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nouvelle Clinique Bonnefon
City
Ales
ZIP/Postal Code
34
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples
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