Head and Neck Cancer
Conditions
Keywords
head and neck cancer, medical device
Brief 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. 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.
Interventions
DEVICEArtificial or Electronic Nose (E-Nose) medical device
medical device detecting breathe-out molecules
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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").
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of Artificial Nose Device for Cancer Detection | At baseline visit | Specificity of the artificial nose classification model in identifying healthy volunteers. |
| Sensitivity of Artificial Nose Device for Cancer Detection | At baseline visit | Sensitivity of the artificial nose classification model in identifying participants with head and neck squamous cell carcinoma. |
Countries
Slovenia
Outcome results
None listed