This study investigates dermoscopic patterns in stratifying skin melanoma risk in patients with a high-risk nevus phenotype. Studying the dermoscopic patterns may improve doctors' ability to identify which people with many moles on their skin are most likely to develop skin melanoma. It may also help doctors use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03080948.
PRIMARY OBJECTIVES:
I. Association between the relative frequencies and anatomic distributions of dermoscopic patterns of nevi and melanoma risk.
II. Reflectance confocal microscopy and histopathology features of anal and 'most atypical' nevi in melanoma cases and unaffected controls.
III. Molecular features of banal and 'most atypical' nevi in melanoma cases and unaffected controls.
IV. Association between germline mutations and nevus phenotype, somatic mutations in nevi, and melanoma risk.
SECONDARY OBJECTIVES:
I. Association between the variability in an individual's clinical attributes of nevi (size, shape, and color) and dermoscopic attributes of nevi (global patterns) and melanoma risk.
II. Correlation between reflectance confocal microscopy and histopathology features and clinical/dermoscopic features of banal and 'most atypical' nevi.
III. Reflectance confocal microscopy and histopathology features of banal and ‘most atypical’ nevi in melanoma cases and, when relevant in subtypes.
IV. Molecular feature of banal and 'most atypical' nevi in melanoma cases and, when feasible, in subtypes.
OUTLINE:
Patients complete a survey over 15-20 minutes and undergo saliva sample collection at baseline. During their clinical visit, patients have a representative banal nevus selected by their dermatologist and undergo standard clinical and dermatoscopic imaging over 1 minute. During a clinical visit for standard 3 dimensional (D)-total body photography, patients also undergo reflectance confocal microscopy (RCM) over 30-40 minutes. Patients then undergo biopsy of the representative banal nevus.
After completion of study, patients are followed up periodically.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAllan C. Halpern