Autoantibody Biomarkers for Melanoma Detection.

The MelDx blood test aims to identify a combination of autoantibodies (including ZBTB7B, PRKCH, TP53, PCTK1, PQBP1, UBE2V1, IRF4, MAPK8_tv2, MSN and TPM1 and potentially other refined combinations of these or new antibodies) in the blood of patients with suspicious lesions thought be be a melanoma. This is a prospective trial aimed to confirm the efficacy, sensitivity and specificity of the melanoma diagnostic test, MelDx, in collaboration with GPs, Skin Check specialists, dermatologists and plastic surgeons. In this trial, • blood will be collected from 1000 participants with suspected melanoma via routine venepuncture prior to the collection of the routine biopsy of the lesion for diagnosis. • The result of the blood test will be compared with that from the biopsy and statistical analyses of the diagnostic accuracy of the MelDx test will be determined. We propose that a blood test based on a diagnostic autoantibody signature (as described in Zaenker et al. 2018) from patient sera can be used in conjunction with current melanoma diagnostic techniques, to improve the early diagnosis and diagnostic certainty of melanoma to ultimately decrease the mortality rate of patients. Hypothesis Autoantibody positivity in sera using the MelDx test will correspond with histological diagnosis of melanoma via biopsy. Primary Aim To validate a combination of autoantibodies that provide diagnostic accuracy of 80% or greater in early stage melanoma. Secondary Aim To evaluate whether a history of skin cancers affects the test results. To evaluate the specificity of MelDx for melanoma relative to other skin cancers, other cancers and autoimmune diseases.