NCT03980977已完成不适用
Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy
Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- skin fibroblast radiosensitivity
研究概览
简要总结
In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child or teenager aged 2 to <18
- •Man, Woman> 18 years old
- •Patient with one of these situations:
- •Unusual toxicity in progress or after radiotherapy
- •Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity
- •Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent
- •Affiliation to a social security scheme.
排除标准
- •Contraindication for skin and / or tumoral biopsy
- •Contraindication for blood sample of 2.5 ml
- •Persons deprived of liberty or under supervision
结局指标
主要结局
skin fibroblast radiosensitivity
时间窗: 2 to 3 months after skin biopsy
The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence
次要结局
- tumor cells radiosensitivity(2 to 3 months after tumor biopsy)
研究者
研究点 (2)
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