TerminatedNot Applicable

Utility of Digital Dermoscopy in the Skin Cancer Clinic

Stopped: COVID pandemic / Change in strategic direction

United Kingdom13 participantsStarted 2018-07-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinician experience questionnaire results

Timeframe: 1 year

Trial details

NCT IDNCT03497455

SponsorBarco NV

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-03-17

View on ClinicalTrials.gov More Skin Cancer trials