Development of an Integrated Multi-channel Artificial Nose for Cancer Detection (UNos)

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.

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.