NCT05474235招募中不适用
Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Blood Collection
研究概览
简要总结
The purpose of this study is to collect, from patients with sporadic and familial ALS and their family members, clinical data and blood samples for extraction of DNA, RNA, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to ALS pathogenesis. Blood samples for DNA extraction also would be collected from control subjects with no personal or family history of ALS phenotypes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •ALS or Suspected ALS Patient
- •Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features; OR
- •Blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features; OR:
- •A clinical suspicion or referral for ALS;
- •> 18 years of age;
- •Willing and able to give signed informed consent or assent that has been approved by the Institutional Review Board (IRB).
- •Blood Relative of ALS Patient
- •Family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
- •> 18 years of age;
- •Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
- •Healthy Control
- •No personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
- •> 18 years of age;
- •No personal history of other neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease);
- •Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
排除标准
- •ALS or Suspected Patient • Limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures.
- •Blood Relative of ALS Patient
- •Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
- •Healthy Control Subject
- •Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.);
- •Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
结局指标
主要结局
Blood Collection
时间窗: 50 years
Total number of blood samples collected
次要结局
未报告次要终点
研究者
Bjorn E. Oskarsson
Principal Investigator
Mayo Clinic
研究点 (2)
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