NCT06033183招募中不适用
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Neolys
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
研究概览
简要总结
Analysis of the individual radiosensitivity in pediatric oncology
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes.
- •Children or adolescents > 3 years old and < 18 years old
- •Patient with an indication for radiotherapy as part of the primary tumor local control strategy
- •Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
- •Patient affiliated with a social security scheme
- •Patient and/or parents or holders of parental authority having dated and signed an informed consent
- •Exclusion criteria:
- •Patients with contraindications to blood sampling
- •Patients with contraindications to radiotherapy
- •Palliative radiotherapy
- •Patient with previous RT treatment in the same area (re-irradiation)
- •Patient with an indication of hypofractionated RT
- •Patient follow-up not possible
- •Persons deprived of liberty or under guardianship (including curatorship)
排除标准
- 未提供
研究组 & 干预措施
Radiosensitivity
Experimental
Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test
干预措施: Blood sample (Biological)
结局指标
主要结局
Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
时间窗: 24 months
evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
次要结局
- Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months(12 months)
研究者
研究点 (2)
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