Characterization of Anti-FGFR3 Antibodies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

Conditions
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Sensory Peripheral Neuropathy

Intervention / Treatment
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* Other: Neurological assessment and Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -Motor or sensory-motor neuropathies Genetic, toxic, paraneoplasic neuropathies Diabetic Neuropathy. Neuropathy with Anti-MAG or anti-ganglioside IgM. Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient<br>Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and positive for anti-FGFR3 antibodies. These patients will have Neurological assessment and Blood sample. | Other: Neurological assessment and Blood sample<br>* Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening<br>|
| control<br>Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies | Other: Neurological assessment and Blood sample<br>* Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure), | Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure), | Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS). | 12 months | 
| Description for patients with anti-FGFR3 antibodies of the immune context | Levels of Antibodies anti-FGFR3 | 6 months | 
| Description for patients with anti-FGFR3 antibodies of the immune context | Levels of Antibodies anti-FGFR3 | 12 months | 
| Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies | Levels of Antibodies anti-FGFR3 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, antibodies antiFGFR3, Biological diagnostic criteria