Melanoma in pigmented cutaneous moles Cancer
Conditions
Interventions
The nomela® test, a technology for capturing digital images of skin lesions and making an analysis by signal-processing. nomela® test output to be compared with histopathology result.
Total duration o
Sponsors
Moletest (Scotland) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients referred on routine clinical decision by the Dermatology/Plastic Surgery Departments for biopsy/excision biopsy and histopathology of suspicious pigmented skin lesions
Exclusion criteria
Exclusion criteria: 1. Other skin conditions not considered to be pigmented moles 2. Lesions not considered suitable for nomela®: pigmented moles smaller than 5mm diameter; moles obscured by hair, scar or tattoos; moles in the mouth, eyelid, nailbed, genital and perianal areas; ulcerated lesions; non-pigmented moles which may be the amelanotic form of melanoma; lesions likely to be basal cell carcinoma, squamous cell carcinoma, Merkel cell tumours, lymphoma, metastatic carcinoma 3. Patients unable or unwilling to give informed consent 4. Patients aged less than 16 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity (95% CI) of the nomela® test for not-melanoma. Measured at a single timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion (95% CI) of lesions that the nomela® test finds as having 'no evidence of melanoma'. Measured at a single timepoint. | — |
Countries
England, United Kingdom
Outcome results
None listed