Utility of Digital Dermoscopy in the Skin Cancer Clinic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-12

Study Completion Date

2020-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer Dermatology/Skin - Other

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Standard medical photographs including dermoscopy images

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

Intervention Type DEVICE

Clinic proforma completion

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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234237

Identifier Type: -

Identifier Source: org_study_id