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临床试验/NCT02417324
NCT02417324招募中不适用

International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours

Universitätsklinikum Hamburg-Eppendorf57 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
57
主要终点
Event free survival

研究概览

简要总结

The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineal tumours, or choroid plexus tumours in Germany and other countries that fulfil national ethic requirements for participation in this registry. These tumours are rare diseases, and many patients are treated outside of clinical trials. The I-HIT-MED registry allows collection of data und biological material from those patients, and provides a basis for standard treatment recommendations and counselling. It aims to improve the international cooperation and the medical knowledge in these rare diseases. Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality assurance in national groups where they are already established, and to support the implementation in national groups, where there is no quality assurance network yet.

详细描述

The following patients can be included in this registry:

Children and adults with

  • Medulloblastoma (MB)
  • Ependymoma
  • Pineal Tumours
  • Chroroid plexus tumours

Objectives of this registry:

To prospectively evaluate the clinical courses of patients with the eligible brain tumours, considering neuroradiological, pathological, and molecular / biological characteristics of the tumour and individual standard treatment data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients with above mentioned diagnosis of all ages (except for ependymoma WHO I°, pineal parenchymal tumour of intermediate differentiation and papillary tumour of the pineal region, who will be registered only if primary diagnosis was before the 18th birthday)
  • any localisation of the primary tumour
  • all clinical stages
  • First diagnosis after 01.01.2012
  • No inclusion into a prospective clinical trial for the same diagnosis, due to non-eligibility, national lack of trial approval, or individual refusal of participation.
  • Written informed consent for data transfer and tumour sample submission according to the laws of each participating country is necessary.
  • National and/ or local ethical committee approval according to the laws of each participating country is necessary.

排除标准

  • Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
  • Lack of valid ethical committee approval.

结局指标

主要结局

Event free survival

时间窗: 10 years

Due to the explorative character of the registry, outcome measures are not strictly defined. We added the most common outcome measures.

次要结局

  • Pattern of relapse(10 years)
  • Overall survival(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (57)

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