NL-OMON43605招募中不适用
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:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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.
排除标准
- •* 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.
研究者
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