Alzheimer DiseaseOLFADIAGNCT03721042
Demonstrating the Diagnostic Power of an Electronic Nose: Study on Exhaled Air Samples
A study testing olfactory measuring device in people with Alzheimer Disease and Gastric Cancer, run by Nouvelle Clinique Bonnefon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Gastric Cancer, Urologic Cancer
- What is being tested?
- olfactory measuring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples
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%.
- Being tested
- olfactory measuring device
- Medical subject headings
- Alzheimer Disease, Stomach Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory measuring deviceDevice
Patients blowing into bags then analysis by olfadiag system
| Study group | Role | What they receive |
|---|---|---|
| exhaled air | Experimental | exhaled air analysis of patients Receives: Device: olfactory measuring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive predictive value and negative predictive value
positive predictive value and negative predictive value of the electronic nose
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start11 Oct 2018
- Primary completion5 Nov 2019
- Study completion1 Oct 2020
Why it stopped: no PI to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nouvelle Clinique Bonnefon
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721042
- Sponsor's protocol ID
- HSM_NCB_2018-1
- Acronym
- OLFADIAG
- Status last verified
- Apr 2022
- First submitted
- 25 Oct 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples
- ClinicalTrials.gov ID
- NCT03721042
- Acronym / sponsor ID
- OLFADIAG / HSM_NCB_2018-1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no PI to continue the study
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nouvelle Clinique BonnefonUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exhaled air | Experimental | Device: olfactory measuring deviceexhaled air analysis of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory measuring devicePatients blowing into bags then analysis by olfadiag system | Device | exhaled air |
Primary outcome
positive predictive value and negative predictive value
Time frame: 18 months
positive predictive value and negative predictive value of the electronic nose
Results and safety
The study was stopped early (reason given: no PI to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory measuring device in people with Alzheimer Disease and Gastric Cancer, run by Nouvelle Clinique Bonnefon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no PI to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive predictive value and negative predictive value (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.