Biomarkers in Polyradiculoneuropathies

NCT04249752 | Unknown

• 1 other identifier: RECHMPL20_0024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Guillain-Barre Syndrome; CIDP

Keywords

chronic inflammatory demyelinating polyradiculoneuropathy; immunostaining; autoantibodies

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (1)

• Screening and titration of antibodies against new antigenic targets in GBS and CIDP patients.

  5 years

Study Arms (2)

Group 1 with GBS patients

GBS patients

Group 2 with CIDP patients

with CIDP patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GBS and CIDP patients according to the diagnostic criteria defined above.

You may qualify if:

• 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

You may not qualify if:

• \- seropositive for anti-ganglioside, anti-MAG, and/or anti-Nfasc155, -CNTN1, -Nfasc186, and -Caspr-1 antibodies

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• CHU de la Timone, Marseille, France: collaborator
• CHU Carémeau, Nîmes, France: collaborator
• University Hospital, Bordeaux: collaborator
• Centre hospitalier de Perpignan: collaborator
• CH de Narbonne, France: collaborator
• CH de Béziers France: collaborator

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, lymphocyte, and cerebrospinal fluid,

MeSH Terms

Conditions

Guillain-Barre Syndrome; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume Taieb, MD

  UH MONTPELLIER

  STUDY DIRECTOR

Central Study Contacts

Guillaume Taieb, MD

CONTACT

467337822; g-taieb@chu-montpellier.fr

Jérôme Devaux, PhD

CONTACT

Jerome.devaux@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 30, 2025
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

FR (1)