Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

Studio Clinico

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.

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT01942603

Data di inserimento: 07.05.2019

Promotore

European Organisation for Research and Treatment of Cancer - EORTC

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Dr.ssa Elisabetta Pennacchioli

Telefono: 0257489459

Email: elisabetta.pennacchioli@ieo.it

Localita: Milano