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Characterization of Anti-FGFR3 Antibodies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02539329
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.


Condition or disease Intervention/treatment
Sensory Peripheral Neuropathy Other: Neurological assessment and Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 465 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies
Actual Study Start Date : February 3, 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood sample for antibodies measure


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539329


Contacts
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Contact: Jean-Christophe ANTOINE, PhD j.christophe.antoine@chu-st-etienne.fr
Contact: Francesco ROTOLO Francesco.Rotolo@chu-st-etienne.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Jean-Christophe ANTOINE, PhD CHU SAINT-ETIENNE
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02539329    
Other Study ID Numbers: 1408060
2014-A00636-41 ( Other Identifier: ANSM )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
neuropathy
antibodies antiFGFR3
Biological diagnostic criteria
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases