Guillain-Barre SyndromeBIPNCT04249752
Biomarkers in Polyradiculoneuropathies
An observational study of Guillain-Barre Syndrome and CIDP, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The nodes of Ranvier contain ion channels that enable the rapid propagation of the nerve impulse. Cell adhesion molecules and glycolipids play an important role in the formation of the nodes of Ranvier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barre Syndrome, CIDP
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 Jan 2025
- 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: GBS and CIDP patients according to the diagnostic criteria defined above.
Who may be able to join
- GBS or CIDP patients over 18 years old
- Signed informed consent
- With a positive immunostaining on wild-type and GalNacT-/- mouse sciatic nerve fibres.
- Subjects must be covered by public health insurance
Who cannot join
- seropositive for anti-ganglioside, anti-MAG, and/or anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies
Trial locations and contacts
1 site in 1 country.
Jérôme Devaux, PhD contact
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Guillaume Taieb, MD, g-taieb@chu-montpellier.fr
Jérôme Devaux, PhD, Jerome.devaux@inserm.fr
About this study
Official title: New Biomarkers in Acute and Chronic Inflammatory Demyelinating Polyradiculoneuropathies
The nodes of Ranvier contain ion channels that enable the rapid propagation of the nerve impulse. Cell adhesion molecules and glycolipids play an important role in the formation of the nodes of Ranvier. Antibodies against glycolipids are detected in half of patients with Guillain-Barré syndrome, an acute inflammatory neuropathy affecting peripheral nerve. The investigators found that antibodies target cell adhesion molecules at nodes of Ranvier in 10% of patients with chronic inflammatory demyelinating neuropathy (CIDP), another disabling neuromuscular disease affecting peripheral nerves. In the majority of patients with GBS or CIDP, the mechanisms responsible for the neuromuscular disorders are unknown. Our goals are to identify novel targets of antibodies in patients, this in order to find novel bio-markers and to better understand the physiopathology of inflammatory neuropathies. This work will help patient diagnosis and treatment orientation.
Read the detailed description
Background: Inflammatory demyelinating polyradiculoneuropathies are rare disabling autoimmune diseases affecting the peripheral nervous system. These neuropathies can be acute, when signs and symptoms raise in less than 1 month (Guillain-Barré syndrome, GBS), or chronic, when deteriorations continue over more than 2 months from onset (CIDP). About half of GBS patients present with IgG1 or IgG3 anti-gangliosides antibodies. Gangliosides are glycolipidic structures mainly localized at the node and paranode areas. In CIDP patients, IgG4 auto-antibodies directed against nodal (Nfasc-186) or paranodal (Nfasc-155, CNTN1, Caspr-1) proteins are found in 5 to 10 %. In most GBS and CIDP patients, the antigenic target are unknown and clinical biomarkers are critically lacking to help diagnosis and treatment orientation. The aim of the present study is to identify new biomarkers in AIDP and CIDP patients.
Methods : The investigators conduct a national retrospective and prospective study to identify new antigenic targets in GBS and CIDP patients. Since 2015, the Institute for Neurosciences of Montpellier and the University Hospitals of Montpellier collect clinical, immulogical, electrophysiological, and histological data of GBS and CIDP patients. Each patient whose serum has already been collected gave written informed consent. GBS and CIDP are diagnosed according to the current criteria. Anti-gangliosides antibodies (by immunodot-blot) and anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies (by ELISA and cell-binding assay) are assessed in GBS and CIDP patients, respectively. Among CIDP patients with monoclonal gammapathy, those presenting with anti-MAG antibodies, increasing VEGF, AL amyloidosis, and neurolymphomatosis are excluded. Patients' serum are also tested by immunohistochemical staining on wild-type and GalNacT -/- mouse sciatic nerve fibres.
Clinical and electrophysiological phenotypes are compared between patients with positive and negative immunostaining. Localization of the staining (i.e. node of Ranvier, paranodal region, and/or myelin sheath) as the subclass and isotype of the autoantibody are specified.
The search for a new antigenic target is performed in GBS and CIDP patients which are i) seronegatives for antiganglioside and anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies, and presenting with ii) a postive immunostaining on wild-type and GalNacT-/- mouse sciatic nerve fibres. Then, serums of these selected patients are incubated with neuronal and glial cells in culture (spinal dorsal ganglia, motoneurons, Schwann cells, oligodendrocytes and neocortical neurons). In the case of positivity against cell culture, an immunoprecipitation is performed and the antigen/antibody complex is separated on SDS-PAGE 4-12% gel and electrophoretic bands are analyzed by mass spectrometry.
The aim of this study is to identify new antigenic targets in seronegative GBS and CIDP patients displaying immunoreactivity. The knowledge of these new targets may improve our diagnostic tools and could help to develop targeted therapies.
- Conditions
- Guillain-Barre Syndrome, CIDP
- Keywords
- chronic inflammatory demyelinating polyradiculoneuropathy, immunostaining, autoantibodies
- Medical subject headings
- Guillain-Barre Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 with GBS patients | GBS patients | |
| Group 2 with CIDP patients | with CIDP patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinical features and immunoreactivity findings in GBS and CIDP patients
Correlation between the localization of the staining (i.e. node of Ranvier, paranodal region, and/or myelin sheath) and the axonal or demyelinating nature of the neuropathy (according to GBS and CIDP criteria).
Measured: 24 months
Secondary outcomes (1)
Screening and titration of antibodies against new antigenic targets in GBS and CIDP patients.
The serums of patients will be considered seropositives when optical density value is ≥ 0.1 in ELISA
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de la Timone, Marseille, France, CHU Carémeau, Nîmes, France, University Hospital, Bordeaux, Perpignan Hospital Center, CH de Narbonne, France, CH de Béziers France
- Responsible party
- Sponsor
- Investigators
- Guillaume Taieb, MD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249752
- Sponsor's protocol ID
- RECHMPL20_0024
- Acronym
- BIP
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers in Acute and Chronic Inflammatory Demyelinating Polyradiculoneuropathies
- ClinicalTrials.gov ID
- NCT04249752
- Acronym / sponsor ID
- BIP / RECHMPL20_0024
- Conditions
- Guillain-Barre Syndrome, CIDP
- Keywords
- chronic inflammatory demyelinating polyradiculoneuropathy, immunostaining, autoantibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- CHU de la Timone, Marseille, France, CHU Carémeau, Nîmes, France, University Hospital, Bordeaux, Perpignan Hospital Center, CH de Narbonne, France, CH de Béziers France
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 31 Jan 2020 (actual)
- 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.
The nodes of Ranvier contain ion channels that enable the rapid propagation of the nerve impulse. Cell adhesion molecules and glycolipids play an important role in the formation of the nodes of Ranvier. Antibodies against glycolipids are detected in half of patients with Guillain-Barré syndrome, an acute inflammatory neuropathy affecting peripheral nerve. The investigators found that antibodies target cell adhesion molecules at nodes of Ranvier in 10% of patients with chronic inflammatory demyelinating neuropathy (CIDP), another disabling neuromuscular disease affecting peripheral nerves. In the majority of patients with GBS or CIDP, the mechanisms responsible for the neuromuscular disorders are unknown. Our goals are to identify novel targets of antibodies in patients, this in order to find novel bio-markers and to better understand the physiopathology of inflammatory neuropathies. This work will help patient diagnosis and treatment orientation.
Detailed description
Background: Inflammatory demyelinating polyradiculoneuropathies are rare disabling autoimmune diseases affecting the peripheral nervous system. These neuropathies can be acute, when signs and symptoms raise in less than 1 month (Guillain-Barré syndrome, GBS), or chronic, when deteriorations continue over more than 2 months from onset (CIDP). About half of GBS patients present with IgG1 or IgG3 anti-gangliosides antibodies. Gangliosides are glycolipidic structures mainly localized at the node and paranode areas. In CIDP patients, IgG4 auto-antibodies directed against nodal (Nfasc-186) or paranodal (Nfasc-155, CNTN1, Caspr-1) proteins are found in 5 to 10 %. In most GBS and CIDP patients, the antigenic target are unknown and clinical biomarkers are critically lacking to help diagnosis and treatment orientation. The aim of the present study is to identify new biomarkers in AIDP and CIDP patients.
Methods : The investigators conduct a national retrospective and prospective study to identify new antigenic targets in GBS and CIDP patients. Since 2015, the Institute for Neurosciences of Montpellier and the University Hospitals of Montpellier collect clinical, immulogical, electrophysiological, and histological data of GBS and CIDP patients. Each patient whose serum has already been collected gave written informed consent. GBS and CIDP are diagnosed according to the current criteria. Anti-gangliosides antibodies (by immunodot-blot) and anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies (by ELISA and cell-binding assay) are assessed in GBS and CIDP patients, respectively. Among CIDP patients with monoclonal gammapathy, those presenting with anti-MAG antibodies, increasing VEGF, AL amyloidosis, and neurolymphomatosis are excluded. Patients' serum are also tested by immunohistochemical staining on wild-type and GalNacT -/- mouse sciatic nerve fibres.
Clinical and electrophysiological phenotypes are compared between patients with positive and negative immunostaining. Localization of the staining (i.e. node of Ranvier, paranodal region, and/or myelin sheath) as the subclass and isotype of the autoantibody are specified.
The search for a new antigenic target is performed in GBS and CIDP patients which are i) seronegatives for antiganglioside and anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies, and presenting with ii) a postive immunostaining on wild-type and GalNacT-/- mouse sciatic nerve fibres. Then, serums of these selected patients are incubated with neuronal and glial cells in culture (spinal dorsal ganglia, motoneurons, Schwann cells, oligodendrocytes and neocortical neurons). In the case of positivity against cell culture, an immunoprecipitation is performed and the antigen/antibody complex is separated on SDS-PAGE 4-12% gel and electrophoretic bands are analyzed by mass spectrometry.
The aim of this study is to identify new antigenic targets in seronegative GBS and CIDP patients displaying immunoreactivity. The knowledge of these new targets may improve our diagnostic tools and could help to develop targeted therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 with GBS patients | – | –GBS patients |
| Group 2 with CIDP patients | – | –with CIDP patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GBS and CIDP patients according to the diagnostic criteria defined above.
Key inclusion criteria (4 listed)
- GBS or CIDP patients over 18 years old
- Signed informed consent
- With a positive immunostaining on wild-type and GalNacT-/- mouse sciatic nerve fibres.
- Subjects must be covered by public health insurance
Key exclusion criteria (1 listed)
- seropositive for anti-ganglioside, anti-MAG, and/or anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between clinical features and immunoreactivity findings in GBS and CIDP patients
Time frame: 24 months
Correlation between the localization of the staining (i.e. node of Ranvier, paranodal region, and/or myelin sheath) and the axonal or demyelinating nature of the neuropathy (according to GBS and CIDP criteria).
1 secondary outcome
Screening and titration of antibodies against new antigenic targets in GBS and CIDP patients.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jérôme Devaux, PhD contact
Guillaume Taieb, MD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-Barre Syndrome and CIDP, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Taieb, MD (467337822 ext. 33, g-taieb@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between clinical features and immunoreactivity findings in GBS and CIDP patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.