Characterization of Anti-FGFR3 Antibodies

February 9, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Characterization of Sensory Neuropathies Associated With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • Creteil, France, 94000
        • CHU CRETEIL
      • Grenoble, France, 38000
        • CHU de Grenoble
      • Limoges, France, 87000
        • chu de Limoges
      • Lyon, France, 69000
        • Hospices Civils de Lyon
      • Marseille, France, 13000
        • AP-HM
      • Nantes, France, 44093
        • CHRU de Nantes
      • Nice, France, 06000
        • CHU de Nice
      • Paris, France, 75013
        • Hôpital Pitié Salpêtrière
      • Paris, France, 75000
        • Hôpital Bicêtre
      • Paris, France, 75019
        • Fondation Rothschild
      • Poitiers, France
        • CHU Poitiers
      • Quimper, France
        • CH Cornouailles
      • Saint-Denis, France
        • CH Saint Denis - Hôpital Delafontaine
      • Saint-etienne, France, 42055
        • CHU Saint-étienne
      • Strasbourg, France, 67000
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient group : patient with clinically pure sensory peripheral neuropathy and positive for anti-FGFR3 antibodies Control group :clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient
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
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
control
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
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening

What is the study measuring?

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),
Time Frame: 6 months
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),
Time Frame: 12 months
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
Time Frame: 6 months
Levels of Antibodies anti-FGFR3
6 months
Description for patients with anti-FGFR3 antibodies of the immune context
Time Frame: 12 months
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
Time Frame: 12 months
Levels of Antibodies anti-FGFR3
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2015

Primary Completion (ACTUAL)

November 15, 2021

Study Completion (ACTUAL)

January 17, 2022

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (ESTIMATE)

September 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408060
  • 2014-A00636-41 (OTHER: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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