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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: Artificial or Electronic Nose (E-Nose) medical device

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head and Neck Cancer Participants - Breath Analysis; 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.	Device: Artificial or Electronic Nose (E-Nose) medical device; medical device detecting breathe-out molecules
Experimental: Healthy Volunteers - Breath Analysis; 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.	Device: Artificial or Electronic Nose (E-Nose) medical device; medical device detecting breathe-out molecules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline visit
Specificity of Artificial Nose Device for Cancer Detection	Specificity of the artificial nose classification model in identifying healthy volunteers.	At baseline visit

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: medical device; head and neck cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Electrical Equipment and Supplies; Diagnostic Equipment; Equipment and Supplies; Electronic Nose
• Other Study ID Numbers: ORI2023-UNOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No