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临床试验/NCT01960751
NCT01960751已完成不适用

Etude Des séquelles Neurocognitives à Long Terme Des Faibles Doses de Radiation Chez 150 Patients traités Par radiothérapie Dans l'Enfance Pour un hémangiome cutané à l'Institut Gustave Roussy (IGR) Entre 1941 et 1973

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2014年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
119
试验地点
1
主要终点
All neurocognitive dysfunction or disorder on adults measured by means of eight tests

研究概览

简要总结

Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France.

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

详细描述

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

CerebRad is a collaborative European project funded in 2011 within the 7th European Union (EU) framework programme, Nuclear Fission and Radiation Protection. CerebRad aims to identify the potential cognitive and cerebrovascular risks of radiation doses below 100 milliGray (mGy) when delivered to a young child (pre- or postnatally).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
  • Inhabitants of Île-de-France
  • French medical insurance
  • Good knowledge and understanding of the French language
  • Non-inclusion Criteria
  • Cerebral hemangioma
  • Syndrome genetic predisposition
  • Pregnant woman
  • Private person of liberty or under guardianship
  • Radiation dose to the brain greater than 1 Gy during radiotherapy treatment of skin hemangioma
  • Chemotherapy during skin hemangioma treatment
  • Inability to undergo counseling for geographical reasons

排除标准

  • Pregnancy
  • Inability to perform neurocognitive tests battery for medical reasons

研究组 & 干预措施

neurocognitive tests

Other

neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)

干预措施: neurocognitive tests battery (Other)

结局指标

主要结局

All neurocognitive dysfunction or disorder on adults measured by means of eight tests

时间窗: Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.

The score to the 8 tests will be correlate with the presence of neurocognitive dysfunction or disorder

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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