Study of Cytokines in Children With Opsoclonus-Myoclonus Syndrome
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 1 - 18 |
| Updated: | 4/2/2016 |
| Start Date: | January 2008 |
| End Date: | December 2016 |
| Contact: | Michael R Pranzatelli, MD |
| Email: | mpranzatelli@siumed.edu |
| Phone: | 2175450836 |
Cytokines as Biomarkers and Therapeutic Targets in Paraneoplastic Opsoclonus-Myoclonus Syndrome (OMS)
The purpose of this study is to determine if cytokines, inflammatory mediators, are
increased in spinal fluid and blood, correlate with disease activity, and could serve as
biomarkers or therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an
autoimmune complication of the tumor neuroblastoma.
increased in spinal fluid and blood, correlate with disease activity, and could serve as
biomarkers or therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an
autoimmune complication of the tumor neuroblastoma.
In this translational research, immunological mechanisms that underlie the assault of the
immune system on the brain in paraneoplastic opsoclonus-myoclonus syndrome (OMS) are under
evaluation. To test our principal hypothesis that there is an imbalance of pro-inflammatory
(Th1) and anti-inflammatory (Th2) cytokines in OMS, a comprehensive cytokine panel will be
measured by enzyme-linked immunosorbent assay (ELISA) and multiplexed fluorescent bead-based
immunoassay detection (LUMINEX 100 Lab MAP system)in blood and cerebrospinal fluid (CSF) of
400 children. To test the second hypothesis that cytokines could serve as biomarkers of
disease activity in OMS, cytokine concentrations will be correlated with clinical variables,
such as disease severity, OMS duration, prior relapses, and remissions, as well as
immunological variables, such as lymphocyte subset analysis. The cytokine 'biomarker
profile' could aid decision making for early intervention by identifying children at high
risk for relapse and poor outcome and allow targeting of the most implicated inflammatory
cytokines by cytokine therapies. To test our third hypothesis that lack of response to
immunotherapy is due in part to failure to increase the expression of anti-inflammatory Th2
cytokines, we will make paired pre/post comparisons of the impact of immunotherapies given
in the course of clinical care [steroids, adrenocorticotropin (ACTH), intravenous
immunoglobulins (IVIg), rituximab, chemotherapy, other drugs, combinations] on the cytokine
and clinical profile. This research could lead to the application of commercially-available
cytokines and cytokine blockers or to the development of new ones for OMS.
immune system on the brain in paraneoplastic opsoclonus-myoclonus syndrome (OMS) are under
evaluation. To test our principal hypothesis that there is an imbalance of pro-inflammatory
(Th1) and anti-inflammatory (Th2) cytokines in OMS, a comprehensive cytokine panel will be
measured by enzyme-linked immunosorbent assay (ELISA) and multiplexed fluorescent bead-based
immunoassay detection (LUMINEX 100 Lab MAP system)in blood and cerebrospinal fluid (CSF) of
400 children. To test the second hypothesis that cytokines could serve as biomarkers of
disease activity in OMS, cytokine concentrations will be correlated with clinical variables,
such as disease severity, OMS duration, prior relapses, and remissions, as well as
immunological variables, such as lymphocyte subset analysis. The cytokine 'biomarker
profile' could aid decision making for early intervention by identifying children at high
risk for relapse and poor outcome and allow targeting of the most implicated inflammatory
cytokines by cytokine therapies. To test our third hypothesis that lack of response to
immunotherapy is due in part to failure to increase the expression of anti-inflammatory Th2
cytokines, we will make paired pre/post comparisons of the impact of immunotherapies given
in the course of clinical care [steroids, adrenocorticotropin (ACTH), intravenous
immunoglobulins (IVIg), rituximab, chemotherapy, other drugs, combinations] on the cytokine
and clinical profile. This research could lead to the application of commercially-available
cytokines and cytokine blockers or to the development of new ones for OMS.
Inclusion Criteria:
- Clinical diagnosis of OMS
Exclusion Criteria:
- Equivocal diagnosis
- Contraindications to lumbar puncture
- Treatment with agents outside the scope of the study
We found this trial at
1
site
Springfield, Illinois 62702
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