Clinical trial NCT03497455: Utility of Digital Dermoscopy in the Skin Cancer Clinic
Official title: Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Skin Cancer
Dermatology/Skin - Other
Lead sponsor: Barco NV
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible \& consenting participants will be approached in a Skin Cancer clinic. Once the clinic consultation has been completed and a decision regarding their management has been made, patients will be invited to consent to the study.

Brief summary: This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.

A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.

All standard macroscopic \& dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.

Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
* Able and willing to comply with all study requirements.
* Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
* Patient attending for a 'New' or 'Follow-up' consultation

Exclusion Criteria:

* Patients aged under 18 years old
* Patients unable to provide informed consent
* Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
* Maximum size of lesion 25 mm
* Lesion is at a site where previous surgery was undertaken
* Lesion on a mucosal site

Primary outcomes:
measure: Clinician experience questionnaire results
timeFrame: 1 year
Secondary outcomes:
measure: Collection of image database
timeFrame: 1 year
measure: Safety of the device for the patient and the user: occurrence of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
References: