♦ No history of a previous melanoma (preceding the melanoma which prompted the SN biopsy) ♦ No previous SN procedure for locally recurrent melanoma or uncertain malignant disease, such as atypical Spitz tumor/naevi ♦ Absence of clinically apparent metastatic disease at the time of or before undergoing a SN procedure If there is more than 1 metastatic SN, the patient will be still eligible provided that all involved SN have minimal tumor burden, regardless of the amount of positive SNs and the basin of interest ♦ regardless of the site, any sub-micrometastasis with a maximum diameter not greater than 0.1 mm ♦ in the sub-capsular space (with no parenchymal infiltration) and with a maximum diameter of the largest metastasis not greater than 0.4 mm ♦ Metastases solely confined within the SN: ♦ Histological evidence of primary cutaneous melanoma T1 and T4 patients will be excluded from the primary aim population, but allowed to enter the registry for descriptive analyses.ĭiagnosis and main criteria for inclusion 5-year DMFI rate is <= 80%) in favor of the alternative (5-year DMFI rate is 87%) with a statistical power of 90% (1-sided alpha=0.05 and beta=0.10, A'Hern design).Īs a drop-out of 7% is expected, the total number of T2-T3 patients to be registered will be increased to 260 patients. If out of these 243 patients, in 38 (15.7%) patients or less a Distant Metastasis is reported within 5 years from their study enrollment, so 205 (84.3%) patients or more are DM-Free at 5-years, then one may reject the null hypothesis (the loss in 5-year DMFI rate is >= 7 %, i.e. It is expected that 243 patients with an T2-T3 primary tumor and minimal SN tumor burden choosing a serial nodal observation will be registered in 5 years. So, for a comparable group of patients, who would not undertake a CLND, an observed loss in the 5-year DMFI rate of approximately 3% would be considered as acceptable a higher observed loss of the DMFI rate, compatible with a true 5-yr DMFI rate of 80 % or lower would be considered to be inacceptable. As generally, the majority of patients who have distant metastasis die within 1-2 years, one may estimate that the 5-year Distant Metastasis Free Interval (DMFI) rate of this group of patients is probably close to 87%. The determination of the sample size was based on results from a more recent evaluation, where patients with melanoma of intermediate Breslow thickness, namely T2-T3 (Breslow thickness 1.01 – 4 mm) (N=110), and minimal SN burden had a 5- and 10-year Melanoma Specific Survival rate of 87% and 80%. Patients will be followed up for 10 years. Data and blood samples for TR will be collected.Īccrual will last approximately 5 years. Participating patients will be registered after signing the informed consent form and after eligibility criteria have been assessed. At each site melanoma patients with minimal SN tumor burden will be managed with CLND or serial nodal observation only according to patient decision, and will be offered the possibility to be included in the registry. However, T1 and T4 patients with minimal SN tumor burden will be allowed to enter the registry for descriptive analyses. Since the focus of this study is represented by patients with minimal SN burden and melanoma of intermediate Breslow thickness, the primary aim population will be composed of T2-T3 (Breslow thickness 1.01-4 mm) patients with minimal SN tumor burden. This is a prospective registry of all melanoma patients with minimal SN tumor burden attending the participating sites, aiming to evaluate whether management of these patients with serial nodal observation only provides an equal outcome than immediate CLND. ♦ We will also determine the actual proportion of patients and their characteristics, who opt to undergo a CLND compared to those, who opt to undergo nodal observation. We will compare this with SN-negative patients, based on historical data as well. ♦ The main objective is to determine if T2-T3 melanoma patients with minimal SN tumor burden and managed by nodal observation have a 5-year DMFI comparable to similar patients (T2-T3 melanoma patients with minimal SN tumor burden) treated by CLND based on historical data from the literature. With this prospective registry we aim to evaluate the outcome of patients with a T2-T3 primary melanoma and minimal SN tumor burden, treated by CLND or nodal observation:
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