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Completed

NCT Number: NCT02539329

Characterization of Anti-FGFR3 Antibodies

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.

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Key information

Conditions

Sensory Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurological assessment and Blood sample

Other

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

Primary outcomes

  1. Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),

    Time frame: 6 months

    Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).

Secondary outcomes

  1. Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),

    Time frame: 12 months

    Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).

  2. Description for patients with anti-FGFR3 antibodies of the immune context

    Time frame: 6 months

    Levels of Antibodies anti-FGFR3

  3. Description for patients with anti-FGFR3 antibodies of the immune context

    Time frame: 12 months

    Levels of Antibodies anti-FGFR3

  4. Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies

    Time frame: 12 months

    Levels of Antibodies anti-FGFR3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Sep 3, 2015
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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