Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Trial Parameters
Brief Summary
This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.
Eligibility Criteria
Inclusion Criteria: * Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed * Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included * Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible. * Participants must have one of the following: * American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease with Breslow thickness \> 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location) * AJCC 8th Ed Clinical Stage IB melanoma * If a melanoma is widely transected and the true Breslow depth is uncertain, then to be eligible for this trial, the melanoma must be re-biopsied to ascertain an accurate Breslow depth. * The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx) * Study intervention (surgery) m