Wise vs Wide: A National, Multicenter, Prospective, Randomized and Controlled, Parallel Group, Non-inferiority Study to Compare Single- vs Two-staged Excisions of Thin Melanoma
The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period.
∙ Patients need to fulfill all criteria listed below:
• Has recently been diagnosed with a primary invasive cutaneous melanoma of Breslow thickness ≤1.0 mm (pT1) as determined by a diagnostic excision with subsequent histopathological analysis that:
‣ Is located on a body location in which a WLE with a 10-mm clinical margin is feasible and would have been planned according to current standard of care.
⁃ Had histopathologically verified free margins of at least 1.5 mm.
• Is 18 years or older at time of consent.
• Is able to give informed consent and comply with the treatment protocol and follow-up plan.
• Has a life expectancy of ≥5 years from the time of diagnosis.