NCT02539329

Characterization of Anti-FGFR3 Antibodies

Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 251 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Sensory Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Neurological assessment and Blood sample	Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening

Timeline

• Start date: 2015-02-03
• Primary completion: 2021-11-15
• Completion: 2022-01-17
• First posted: 2015-09-03
• Last updated: 2023-02-10

Locations

17 sites across 1 country: France