- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539329
Characterization of Anti-FGFR3 Antibodies
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
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Jean-Christophe ANTOINE, PhD
- Email: j.christophe.antoine@chu-st-etienne.fr
Study Contact Backup
- Name: Francesco ROTOLO
- Email: Francesco.Rotolo@chu-st-etienne.fr
Study Locations
-
-
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Bordeaux, France
- CHU Bordeaux
-
Clermont-Ferrand, France
- CHU Clermont-Ferrand
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Creteil, France, 94000
- CHU Créteil
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Grenoble, France, 38000
- CHU de Grenoble
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Limoges, France, 87000
- chu de Limoges
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Lyon, France, 69000
- Hospices Civils de Lyon
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Marseille, France, 13000
- AP-HM
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Nantes, France, 44093
- CHRU de Nantes
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Nice, France, 06000
- Chu de Nice
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Paris, France, 75013
- Hopital Pitie Salpetriere
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Paris, France, 75000
- Hopital Bicetre
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Paris, France, 75019
- Fondation Rothschild
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Poitiers, France
- CHU Poitiers
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Quimper, France
- CH Cornouailles
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Saint-Denis, France
- CH Saint Denis - Hôpital Delafontaine
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Saint-etienne, France, 42055
- Chu Saint-Etienne
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Strasbourg, France, 67000
- CHU Strasbourg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
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
|
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
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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