Utility of Digital Dermoscopy in the Skin Cancer Clinic

Skin Cancer Clinical Trial

Official title:

Feasibility Study to Evaluate Utility of the BARCO NV Digital Dermatoscope in the Skin Cancer Clinic

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03497455
• Other study ID #: 234237
• Status: Terminated
• Start date: July 12, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: December 2021
• Source: Barco NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatology/Skin - Other
• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Barco NV Digital Dermatoscope device images
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
Images taken by medical photographer as part of standard care in the medical photography suite.

Other:
• Clinic proforma completion
This is part of standard care and will be undertaken by the clinician who is responsible for the patient

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Barco NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Collection of image database	Anonymised database of clinicopathological and digital images of benign, malignant and equivocal skin lesions + Proportion of high quality images amenable to clinician evaluation	1 year
Secondary	Safety of the device for the patient and the user: occurrence of adverse events	Number of adverse events reported	1 year