Utility of Digital Dermoscopy in the Skin Cancer Clinic

NCT03497455 | Terminated

• 1 other identifier: 234237
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer; Dermatology/Skin - Other

Outcome Measures

Primary Outcomes (1)

• Clinician experience questionnaire results

  To assess the acceptability of the new dermoscope in the skin cancer clinic, questions about the usability of the device and about the image quality of the obtained dermoscopic pictures are included.

  1 year

Secondary Outcomes (2)

• Collection of image database

  1 year

• Safety of the device for the patient and the user: occurrence of adverse events

  1 year

Interventions

Barco NV Digital Dermatoscope device images DEVICE

Images taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist

Standard medical photographs including dermoscopy images DEVICE

Images taken by medical photographer as part of standard care in the medical photography suite.

Clinic proforma completion OTHER

This is part of standard care and will be undertaken by the clinician who is responsible for the patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barco NV: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 13, 2018
• Study Start: July 12, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

GB (1)