![]() ![]() The frequency of the sites involved also differs by ethnicity. The incidence of melanoma per 100,000 people in 1999 was 21.3 in Caucasians and 1.3 in Asians, but in 2008, it reached 26.5 in Caucasians and 1.6 in Asians. The incidence of melanoma differs by ethnicity but has been increasing recently among all populations. Ethical approval was obtained from each institution’s Institutional Review Board prior to patient enrollment. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in August 2017, and patient enrollment began in November 2017. A total of 85 patients from 21 Japanese institutions will be recruited within 5.5 years, and the follow-up period will last at least 5 years. The primary endpoint is major relapse-free survival (major RFS), which does not include local recurrence as an event secondary endpoints include overall survival, digit-preservation survival, relapse-free survival, local relapse-free survival, partial relapse-free survival, and incidence of adverse events. Patients aged between 20 and 80 years with stage I, II, or III without evidence of tumor invasion to the underlying distal phalanx on preoperative radiograph are included in the study. We will compare our results with those reported in the Japanese Melanoma Study, in which patients underwent amputation for SUMs as a traditional standard of care. ![]() We are conducting a multi-institutional single-arm trial to confirm the safety and efficacy of non-amputative digit preservation surgery. ![]()
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