Sensory Peripheral NeuropathyNCT02539329
Characterization of Anti-FGFR3 Antibodies
An observational study of Sensory Peripheral Neuropathy, run by Centre Hospitalier Universitaire de Saint Etienne at 17 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensory Peripheral Neuropathy
- What is being tested?
- Neurological assessment and Blood sample
- How many people
- 251 participants
- Where
- 17 sitesFrance
- Study dates
- 3 Feb 2015to 17 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- -Motor or sensory-motor neuropathies
- Genetic, toxic, paraneoplasic neuropathies
- Diabetic Neuropathy.
- Neuropathy with Anti-MAG or anti-ganglioside IgM.
- Pregnant or breastfeeding woman
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Bordeaux
Bordeaux
CHU Clermont-Ferrand
Clermont-Ferrand
Chu Creteil
Créteil, 94000
CHU de Grenoble
Grenoble, 38000
CHU de Limoges
Limoges, 87000
Hospices Civils de Lyon
Lyon, 69000
AP-HM
Marseille, 13000
CHRU de Nantes
Nantes, 44093
CHU de NICE
Nice, 06000
Hôpital BICETRE
Paris, 75000
Hopital Pitie Salpetriere
Paris, 75013
Fondation Rothschild
Paris, 75019
CHU Poitiers
Poitiers
CH Cornouailles
Quimper
CH Saint Denis - Hôpital Delafontaine
Saint-Denis
Chu Saint-Etienne
Saint-Etienne, 42055
Chu Strasbourg
Strasbourg, 67000
About this study
Official title: 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.
Read the 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
- Being tested
- Neurological assessment and Blood sample
- Keywords
- neuropathy, antibodies antiFGFR3, Biological diagnostic criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological assessment and Blood sampleOther
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurological assessment and Blood sample | |
| control | Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies Receives: Other: Neurological assessment and Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).
Measured: 6 months
Secondary outcomes (4)
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).
Measured: 12 months
Description for patients with anti-FGFR3 antibodies of the immune context
Levels of Antibodies anti-FGFR3
Measured: 6 months
Description for patients with anti-FGFR3 antibodies of the immune context
Levels of Antibodies anti-FGFR3
Measured: 12 months
Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies
Levels of Antibodies anti-FGFR3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start3 Feb 2015
- Primary completion15 Nov 2021
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensory Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe ANTOINE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539329
- Sponsor's protocol ID
- 1408060
- Other IDs
- 2014-A00636-41
- Status last verified
- Feb 2023
- First submitted
- 31 Jul 2015
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassabliere F, Reynaud-Federspiel E, Franca MC Jr, Martinez ARM, Camdessanche JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.
PubMed 31690697
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies
- ClinicalTrials.gov ID
- NCT02539329
- Acronym / sponsor ID
- 1408060
- Conditions
- Sensory Peripheral Neuropathy
- Keywords
- neuropathy, antibodies antiFGFR3, Biological diagnostic criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: Neurological assessment and Blood sampleMale 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. |
| control | – | Other: Neurological assessment and Blood sampleMale or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- A :Patients Male or female patient aged 18 years or more
- idiopathic or dysimmune sensory neuronopathies
- idiopathic or dysimmune distal axonal sensory neuropathy
- sensory chronic inflammatory demyelinating polyradiculoneuropathy
- idiopathic or dysimmune small fiber neuropathies
Key exclusion criteria (5 listed)
- -Motor or sensory-motor neuropathies
- Genetic, toxic, paraneoplasic neuropathies
- Diabetic Neuropathy.
- Neuropathy with Anti-MAG or anti-ganglioside IgM.
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological assessment and Blood sampleNeurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening | Other | control, patient |
Primary outcome
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).
4 secondary outcomes
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
Time frame: 12 months
Description for patients with anti-FGFR3 antibodies of the immune context
Time frame: 6 months
Description for patients with anti-FGFR3 antibodies of the immune context
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 31690697Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassabliere F, Reynaud-Federspiel E, Franca MC Jr, Martinez ARM, Camdessanche JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe ANTOINE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Peripheral Neuropathy, run by Centre Hospitalier Universitaire de Saint Etienne at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure), (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.