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临床试验/NCT03690570
NCT03690570Unknown不适用

Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年5月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Assessment of patient survival associated with relapse rate after surgery

研究概览

简要总结

High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules

研究设计

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

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children under 5 years old
  • High grade glioma (WHO status III or IV)
  • No previous treatment with chemotherapy or radiotherapy
  • No contraindication to chemotherapy
  • Consent of legal representative for participation in the study

排除标准

  • Low grade glioma
  • Any other histological pattern
  • Parent's denial to access data concerning their child in the frame of medical research

结局指标

主要结局

Assessment of patient survival associated with relapse rate after surgery

时间窗: 10 years

Assessment of patient survival associated with relapse rate after chemotherapy

时间窗: 10 years

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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