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 - EORTC 1208: MINITUB

European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•* 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
•* 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 basin of interest
•* Absence of clinically apparent metastatic disease at the time of or before undergoing a SN procedure
•* Age >=18 years
•* 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
•* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

•* No previous SN procedure for locally recurrent melanoma or uncertain malignant disease, such as atypical Spitz tumor/naevi
•* No history of a previous melanoma (preceding the melanoma which prompted the SN biopsy)
•* 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.

发起方

European Organisation for Research in Treatment of Cancer (EORTC)