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COVID pandemic / Change in strategic direction
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Safety of the device for the patient and the user: occurrence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Number of adverse events reported |
| 1 year |