Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Expression of P2X4 receptor
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Our associated laboratory has identified the P2X4 purinergic pathway that appears to be involved in the pathogenesis of ALS. Our goal is to verify these results at the human level in order to have a proof of concept of P2X4's role as a biomarker of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •For ALS group: Person presenting a probable or confirmed diagnosis of ALS according to the criteria of EI Escorial.
- •Person affiliated or beneficiary of a social security scheme.
- •Free, informed and written consent signed by the participant or by a third person (in case of physical incapacity of the participant), after information on the study.
排除标准
- •People undergoing immunosuppressive or corticosteroid treatments.
- •Participation in a research protocol with an experimental treatment.
- •People placed under guardianship, curatorship or legal protection.
- •For healthy volunteer, people directly related to the patient (siblings, descendants and ancestry).
研究组 & 干预措施
ALS patient
During the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care, patients will be informed about the protocol and their informed consent will be obtained.
A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken.
For ALS patients, a follow-up visit will be performed at 6 months as part of their follow-up consultation at the ALS center. The same examinations as on D0 will be done.
干预措施: P2X4 receptors in blood samples (Diagnostic Test)
Standard : healthy subjects
During the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care. A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken.
For healthy subjects, a follow-up visit will be performed at 6 months. The same examinations as on D0 will be done.
干预措施: P2X4 receptors in blood samples (Diagnostic Test)
结局指标
主要结局
Expression of P2X4 receptor
时间窗: 6 months after Day 0
Compare expression of P2X4 receptor in ALS patients versus healthy subjects to demonstrate its role as a clinical biomarker of ALS. Comparison will be obtained by labeling and flow cytometer analysis of circulating monocytes.
次要结局
- Diagnostic performance(6 months after Day 0)
- Prognostic performances(6 months after Day 0)
- P2X4 receptor levels evolution(6 months after Day 0)
- Levels of P2X4 receptors between patients with familial or sporadic ALS.(6 months after Day 0)
- P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1antisense(6 months after Day 0)