Melanoma Detection System (MDS) Clinical Utility Study
Research type
Research Study
Full title
Investigating the clinical utility of the Melanoma Detection System (MDS) test for the oncogenic activity in nevi suspected of being melanoma.
IRAS ID
209107
Contact name
Girsh Gupta
Contact email
Sponsor organisation
Orlucent Inc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 4 days
Research summary
Currently, the standard method for detecting melanoma is skin examination and dermoscopy performed be a dermatologist. Definite diagnosis can be difficult and there is a risk of missing early melanoma. Therefore, many lesions which look atypical, but may not be melanoma are removed. The Melanoma Detection System provides information about the biological processes occurring in a lesion as it turns into malignant melanoma.
This is a non-interventional, single-arm study to determine whether the MDS, in conjunction with clinical evaluation, would improve the decision of whether to urgently remove a suspicious lesion and whether MDS alone would provide superior results to clinical evaluation alone. MDS results will be retrospectively compared to the treatment decision and pathology results
Enrolment will take up to six months. Total study duration is 11 months to allow for collation of information after treatment is complete.Participants will be recruited from adults who have been referred by their GP to one of four NHS secondary care clinics for examination of lesions (moles) that are suspected of being melanoma. The study is funded by Orlucent Inc., the manufacturer of the test. Patients will undergo the MDS test in parallel to their routine examination and treatment.
The test will be performed before the lesion is removed either at the first appointment or prior to surgery. No additional visits or care will be required for the study.
The MDS test involves a dye being applied to the surface of the skin. The dye has been tested to be safe and will wash off. It binds to proteins that are released when a mole turns into melanoma. Then, photographs are taken are taken under white and infra-red light. These images are analysed using MDS software which provides a score that indicates the likelihood for the presence of melanoma. The test takes less than 10 minutes.REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/1672
Date of REC Opinion
9 Nov 2017
REC opinion
Further Information Favourable Opinion