Validation of Radio-induced Damage Biomarkers (BIOM-DRI)
Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study
研究概览
详细说明
The nuclear and radiologic risks monitoring is a major preoccupation for our society. During an accident, it is primordial to define the biologic dosimetry. The dose and distribution knowledge is crucial for the medical care. Indeed, Total Body Irradiation (TBI) and Partial Body Irradiation (PBI) do not have the same clinical outcome. A Total Body Irradiation induces an acute radiation syndrome with a Medullary Aplasia. A quick diagnostic would allow the optimization of the medical care.
Nowadays, the analyse of the chromosome with two centromeres is the current norm to estimate the radiation dose, but this technique is time consuming, and not adapted to an emergency situation, and to a large population.
The new genetic techniques could permit the quick radiation dosimetry diagnosis. The research of early exposition bio-markers seems to be of a major interest. These bio-markers would allow to rapidly define the radiations perceived by an exposed subject, before the apparition of the symptoms, and by the way, to conduct to a therapeutic strategy more adapted to the patient.
In this purpose, the present study will need blood and urines samples of patients totally or partially exposed to radiations, according to their usual medical care.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Saint-Priest en Jarez、法国、42270
- Institut de Cancérologie Lucien Neuwirth
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Villejuif、法国、94800
- Institut Gustave Roussy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- More than 18 years old
- For the group A:
Patient suffering from a malignant blood disease requiring a whole-body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 Gray per day, during 3 days.
- OR For the group B:
Patient with one (or more) pelvis metastasis requiring radiation therapy without concomitant chemotherapy, according to the following protocol: 4 Gray per day for 5 days.
Exclusion Criteria:
- More than 70 years old,
- Subject presenting abnormal blood count (grade 3),
- Person with a not controlled chronic illness,
- Subject presenting an abnormal hepatic assessment (grade 3),
- Subject having already received ionizing treatments,
- Subject reached HIV, hepatitis C or any other progressive infectious diseases,
- Pregnant women or nursing mothers,
- Person under protection of justice or unable to give consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Total Body Irradiation
Patient suffering from a malignant blood disease that requires a total body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 Gray per day, for 3 days.
Blood and urines samples will be performed at days 0, 1, 2 and 3 of the treatment plan.
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For all patients the blood samples must be organized: Before, 4 hours (+/-30 min), 1 day, 2 days, and 3 days after the start of the radiation therapy. Collections of urine must be organized: Before, 1 day, and 2 days after the radiation therapy. |
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实验性的：Partial Body Irradiation
Patient with at least one bone metastasis localized at the pelvis and requiring partial body radiation therapy without associated chemotherapy, according to the following protocol: 4 Gray per day for 5 days will perform blood and urines samples at days 0, 1, 2 and 3 after the beginning of the radiation treatment.
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For all patients the blood samples must be organized: Before, 4 hours (+/-30 min), 1 day, 2 days, and 3 days after the start of the radiation therapy. Collections of urine must be organized: Before, 1 day, and 2 days after the radiation therapy. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Level of haematological and biochemical markers
大体时间：Day 3
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The following bio-markers levels will be calculated :
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Day 3
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Quantification of chromosomal aberrations
大体时间：Day 3
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Quantification of chromosomal aberrations will be performed on the blood samples performed at days 0, 1, 2 and 3 after the beginning of the rays perform in the usual practice.
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Day 3
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Detection of biochemical markers
大体时间：Day 3
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The presence or absence of these markers will be notified:
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Day 3
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Metabolomics markers levels
大体时间：Day 2
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The metabolomic levels of the following molecules will be calculated on urine samples:
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Day 2
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total dose of radiation
大体时间：Day 3
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The total dose of radiation will be calculated for each patient and compared will the biologic results.
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Day 3
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Radiation field
大体时间：Day 3
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The radiation field will be define for each patient and compared with the biological results.
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Day 3
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2016-0901
- 2016-A01446-45 (其他标识符：ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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