Patologia: Melanoma
Osservazionale-Sperimentale: Osservazionale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: Non applicabile
Richiesta mandatoria di tessuto: No
Linee di trattamento: Non applicabile
Criteri di inclusione:
- 18 years of age or older
- Histological evidence of primary cutaneous melanoma
- Metastases solely confined within the SN:
- in the sub-capsular space (with no parenchymal infiltration) and with a maximum diameter of the largest metastasis not greater than 0.4 mm or
- regardless of the site, any sub-micrometastasis with a maximum diameter not greater than 0.1 mm 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 interested basin
Criteri di esclusione:
- No history of any other malignancy within the past 5 years, except for non-melanoma skin cancer (Basal Cell Carcinomas or Squamous Cell Carcinomas) and in situ cervical cancer
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trattamento sperimentale:
NA
Trattamento di controllo:
NA
Obiettivi primari dello studio:
The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Dr.ssa Elisabetta Pennacchioli
Telefono: 0257489459
Email: elisabetta.pennacchioli@ieo.it
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Riferimento: Dr. Marco Rastrelli
Telefono: 0498215594
Email: marco.rastrelli@iov.veneto.it
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Corrado Caracò
Telefono: 0815903741
Email: corrado.caraco@istitutotumori.na.it
Numero di iscrizione a registro: NCT01942603
Data di inserimento: 07.05.2019
European Organisation for Research and Treatment of Cancer - EORTC
/
Istituto Europeo di Oncologia, Milano
Riferimento: Dr.ssa Elisabetta Pennacchioli
Telefono: 0257489459
Email: elisabetta.pennacchioli@ieo.it
Localita: Milano