NCT05433974Unknown不适用
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
Centre Francois Baclesse, Luxembourg0 个研究点目标入组 200 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Validation of RadioDtect test on early radiation-induced toxicity
研究概览
简要总结
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Patient over 18 years old
- •Patient with an indication for curative radiotherapy
- •Patient having given his signed written informed consent before any specific procedure of the protocol.
排除标准
- •Patient with a contraindication to radiotherapy
- •Patient with an indication for palliative radiotherapy
- •Patient with a history of radiotherapy in the area where the cancer is located
- •Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
研究组 & 干预措施
Radiosensitivity
Other
Patient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test.
干预措施: Blood sample collection (Biological)
结局指标
主要结局
Validation of RadioDtect test on early radiation-induced toxicity
时间窗: 3 months
prospectively validate the predictive capacities of the RadioDtect individual radiosensitivity blood test on early radiation-induced toxicity. The validation will be based on ATM protein assay and rate of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
次要结局
- Validation of RadioDtect test on delayed radiation-induced toxicity(12 months)
研究者
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