Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 17
- 主要终点
- Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
研究概览
简要总结
Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.
However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.
详细描述
In and out patients evaluated for a sensory neuropathy meeting the inclusion and non-inclusion criteria will be proposed to enter the study
At inclusion the SSN diagnostic score is calculated and a blood sample is tested for anti-FGFR3 antibody.
Follow up: Patients positive for anti-FGFR3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. A blood sample is taken at 6 and 12 months.
A subgroup of patients negative for anti-FGFR3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •A :Patients Male or female patient aged 18 years or more
- •Patients with a clinically pure sensory peripheral neuropathy including :
- •idiopathic or dysimmune sensory neuronopathies
- •idiopathic or dysimmune distal axonal sensory neuropathy
- •sensory chronic inflammatory demyelinating polyradiculoneuropathy
- •idiopathic or dysimmune small fiber neuropathies
- •idiopathic or dysimmune trigeminal nerve neuropathy
- •positive to antibodies anti-FGFR3
- •B :Controls Male or female patient aged 18 years or more
- •Patients with a clinically pure sensory peripheral neuropathy including :
- •idiopathic or dysimmune sensory neuronopathies
- •idiopathic or dysimmune distal axonal sensory neuropathy
- •sensory chronic inflammatory demyelinating polyradiculoneuropathy
- •idiopathic or dysimmune small fiber neuropathies
- •idiopathic or dysimmune trigeminal nerve neuropathy
- •negative to antibodies anti-FGFR3
排除标准
- •-Motor or sensory-motor neuropathies
- •Genetic, toxic, paraneoplasic neuropathies
- •Diabetic Neuropathy.
- •Neuropathy with Anti-MAG or anti-ganglioside IgM.
- •Pregnant or breastfeeding woman
结局指标
主要结局
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
时间窗: 6 months
Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).
次要结局
- Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),(12 months)
- Description for patients with anti-FGFR3 antibodies of the immune context(12 months)
- Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies(12 months)