Head and Neck CancerUNOSNCT07419113
Development of an Integrated Multi-channel Artificial Nose for Cancer Detection (UNos)
A study testing Artificial or Electronic Nose (E-Nose) medical device in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This interventional diagnostic study evaluated a multi-channel artificial nose (UNos) medical device for analysis of exhaled breath in participants with head and neck squamous cell carcinoma and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Artificial or Electronic Nose (E-Nose) medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Feb 2023to 1 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- Non-smokers and smokers
- Aged over 18 years.
- The person must be able to understand and sign the consent form for participation in the clinical trial ("informed consent").
Who cannot join
- Throat or pharyngeal cancer that is not squamous cell carcinoma
- Known malignant disease elsewhere in the body.
- Previously treated malignant disease anywhere in the body, with the exception of non-melanoma skin cancer or cervical CIS
- Diabetes.
- Age under 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
This interventional diagnostic study evaluated a multi-channel artificial nose (UNos) medical device for analysis of exhaled breath in participants with head and neck squamous cell carcinoma and healthy volunteers. Participants underwent a standardized breath sampling procedure, and exhaled air was analyzed using semi-selective sensor arrays to generate quantitative breath pattern signatures. The study evaluated the ability of the device to discriminate cancer participants from healthy controls based on sensor-derived breath profiles.
Read the detailed description
This prospective, non-randomized, interventional diagnostic study evaluated the performance of a multi-channel artificial nose (UNos) medical device for exhaled breath analysis in participants with head and neck squamous cell carcinoma and in healthy volunteers.
Participants were assigned to one of two parallel groups:
Adults with histologically confirmed squamous cell carcinoma of the head and neck.
Healthy adult volunteers without known malignant disease.
All participants underwent a standardized breath collection procedure according to the study protocol. Exhaled breath samples were collected into gas sampling bags under controlled conditions and subsequently analyzed using a multi-channel electronic nose system equipped with semi-selective chemical sensors designed to detect volatile organic compound-related signal patterns.
The device generated quantitative sensor response values for each participant. These normalized sensor features were used for statistical classification modeling to distinguish cancer participants from healthy volunteers.
Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis, including calculation of area under the curve (AUC), sensitivity, and specificity.
The breath sampling and analysis procedure was non-invasive and did not influence clinical management. No therapeutic intervention was performed. Enrollment was completed with 45 participants.
- Conditions
- Head and Neck Cancer
- Being tested
- Artificial or Electronic Nose (E-Nose) medical device
- Keywords
- head and neck cancer, medical device
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial or Electronic Nose (E-Nose) medical deviceDevice
medical device detecting breathe-out molecules
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer Participants - Breath Analysis | Experimental | Participants with histologically confirmed head and neck squamous cell carcinoma underwent a standardized exhaled breath sampling procedure according to study protocol. Breath samples were collected into gas sampling bags under controlled conditions and analyzed using a multi-channel artificial nose (UNos) medical device equipped with semi-selective chemical sensors. The device generated quantitative sensor response values representing volatile organic compound patterns in exhaled air. No therapeutic intervention was performed, and the procedure did not influence clinical management. Receives: Device: Artificial or Electronic Nose (E-Nose) medical device |
| Healthy Volunteers - Breath Analysis | Experimental | Healthy adult volunteers underwent the same standardized exhaled breath sampling procedure as cancer participants. Breath samples were collected into gas sampling bags and analyzed using the multi-channel artificial nose (UNos) system to obtain quantitative sensor response patterns. The procedure was non-invasive and performed for diagnostic signal acquisition only, without any therapeutic intervention. Receives: Device: Artificial or Electronic Nose (E-Nose) medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification
Area under the receiver operating characteristic (ROC) curve calculated from the artificial nose device classification model distinguishing participants with head and neck squamous cell carcinoma from healthy volunteers.
Measured: At baseline visit
Secondary outcomes (2)
Sensitivity of Artificial Nose Device for Cancer Detection
Sensitivity of the artificial nose classification model in identifying participants with head and neck squamous cell carcinoma.
Measured: At baseline visit
Specificity of Artificial Nose Device for Cancer Detection
Specificity of the artificial nose classification model in identifying healthy volunteers.
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Feb 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419113
- Sponsor's protocol ID
- ORI2023-UNOS
- Acronym
- UNOS
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 24 Feb 2026
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Integrated Multi-channel Artificial Nose for Cancer Detection (UNos)
- ClinicalTrials.gov ID
- NCT07419113
- Acronym / sponsor ID
- UNOS / ORI2023-UNOS
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 18 Feb 2026 (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.
This interventional diagnostic study evaluated a multi-channel artificial nose (UNos) medical device for analysis of exhaled breath in participants with head and neck squamous cell carcinoma and healthy volunteers. Participants underwent a standardized breath sampling procedure, and exhaled air was analyzed using semi-selective sensor arrays to generate quantitative breath pattern signatures. The study evaluated the ability of the device to discriminate cancer participants from healthy controls based on sensor-derived breath profiles.
Detailed description
This prospective, non-randomized, interventional diagnostic study evaluated the performance of a multi-channel artificial nose (UNos) medical device for exhaled breath analysis in participants with head and neck squamous cell carcinoma and in healthy volunteers.
Participants were assigned to one of two parallel groups:
Adults with histologically confirmed squamous cell carcinoma of the head and neck.
Healthy adult volunteers without known malignant disease.
All participants underwent a standardized breath collection procedure according to the study protocol. Exhaled breath samples were collected into gas sampling bags under controlled conditions and subsequently analyzed using a multi-channel electronic nose system equipped with semi-selective chemical sensors designed to detect volatile organic compound-related signal patterns.
The device generated quantitative sensor response values for each participant. These normalized sensor features were used for statistical classification modeling to distinguish cancer participants from healthy volunteers.
Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis, including calculation of area under the curve (AUC), sensitivity, and specificity.
The breath sampling and analysis procedure was non-invasive and did not influence clinical management. No therapeutic intervention was performed. Enrollment was completed with 45 participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer Participants - Breath Analysis | Experimental | Device: Artificial or Electronic Nose (E-Nose) medical deviceParticipants with histologically confirmed head and neck squamous cell carcinoma underwent a standardized exhaled breath sampling procedure according to study protocol. Breath samples were collected into gas sampling bags under controlled conditions and analyzed using a multi-channel artificial nose (UNos) medical device equipped with semi-selective chemical sensors. The device generated quantitative sensor response values representing volatile organic compound patterns in exhaled air. No therapeutic intervention was performed, and the procedure did not influence clinical management. |
| Healthy Volunteers - Breath Analysis | Experimental | Device: Artificial or Electronic Nose (E-Nose) medical deviceHealthy adult volunteers underwent the same standardized exhaled breath sampling procedure as cancer participants. Breath samples were collected into gas sampling bags and analyzed using the multi-channel artificial nose (UNos) system to obtain quantitative sensor response patterns. The procedure was non-invasive and performed for diagnostic signal acquisition only, without any therapeutic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers.
- Non-smokers and smokers
- Aged over 18 years.
- The person must be able to understand and sign the consent form for participation in the clinical trial ("informed consent").
Key exclusion criteria (5 listed)
- Throat or pharyngeal cancer that is not squamous cell carcinoma
- Known malignant disease elsewhere in the body.
- Previously treated malignant disease anywhere in the body, with the exception of non-melanoma skin cancer or cervical CIS
- Diabetes.
- Age under 18 years.
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 |
|---|---|---|
| Artificial or Electronic Nose (E-Nose) medical devicemedical device detecting breathe-out molecules | Device | Head and Neck Cancer Participants - Breath Analysis, Healthy Volunteers - Breath Analysis |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification
Time frame: At baseline visit
Area under the receiver operating characteristic (ROC) curve calculated from the artificial nose device classification model distinguishing participants with head and neck squamous cell carcinoma from healthy volunteers.
2 secondary outcomes
Sensitivity of Artificial Nose Device for Cancer Detection
Time frame: At baseline visit
Specificity of Artificial Nose Device for Cancer Detection
Time frame: At baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- 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 Artificial or Electronic Nose (E-Nose) medical device in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Feb 2026. 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 Slovenia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification (time frame: At baseline visit). 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 24 Feb 2026.