Biological prognostic factors for anti-MAG neuropathy
Research type
Research Study
Full title
A study of biological prognostic factors for IgM paraproteinemic anti-MAG associated peripheral neuropathy.
IRAS ID
126547
Contact name
Michael Lunn
Contact email
Sponsor organisation
University College London
Research summary
The objective is to determine biological factors in blood and CSF that could be predictive of severity of neuropathies associated with IgM anti-MAG antibodies.
Anti-MAG neuropathies have a variable severity and some have a non-significant response to immunotherapies, but all have significant risks of potentially severe adverse effects from treatment. It seems important to find predictive factors to determine which patients have a high risk of evolution to severe disability so treatment would be targeted to appropriate patients. We suggest studying some factors which could influence the disease evolution including molecules that regulate the monoclonal IgM secreting B-cells (BAFF, APRIL, inflammatory cytokines), and molecules that may modulate the alteration of the blood-nerve barrier (inflammatory cytokines, VEGFs, angiopoietins).
This is a retrospective cohort study, including patients from the National Hospital For Neurology, London, UK, and from the University Hospital of Rennes, France. This research is expected to assess at least 45 patients.
Patients should fulfill the EFNS-PNS criteria for IgM anti-MAG neuropathy.
Neurological, electrophysiological and biological data will be collected retrospectively. A sera and CSF bank will allow retrospective biological dosages. All the patients will be evaluated in 2013 for neurological, electrophysiological and biological examinations.
A control group will include sera and CSF from healthy subjects, and a population of CIDP, diabetic neuropathy, auto-immune diseases, and IgM dysglobulinemia without neuropathy.
A retrospective analysis of each patient will allow us to define the progression of the clinical and electrophysiological scores. These data will be correlated with the initial biological data from the bank of serum and CSF in order to study the predictive value of the studied molecules.
Inclusions will start in April 2013 and will end in september 2013. Biomarkers testing will last until october 2013. Statistical analysis, interpretation of the findings and final report will be done from october to december 2013.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0222
Date of REC Opinion
22 Jul 2013
REC opinion
Further Information Favourable Opinion