CompletedNot Applicable

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

Slovenia45 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification

Timeframe: At baseline visit

Trial details

NCT IDNCT07419113

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Head and Neck Cancer trials