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| Sponsored by: |
University of California, Davis |
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00704626 |
Purpose
Under normal conditions our immune system protects us against infections and tumors. The immune system does this by recognizing that the infecting organism or the tumor is foreign to the body and attacking it. One way the immune system attacks a foreign target is by making proteins called antibodies that bind to the target. Sometimes, for reasons we poorly understand, the immune system wrongly identifies part of our own body as being foreign and attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as well as some neurological diseases. In this study, one tablespoon of blood will be removed from each subject and tested to see if the immune system is making antibodies against components of the nerves and muscles. We also hope to learn if these antibodies contribute to the development or worsening of illnesses of the nervous system. Only one blood draw is required, but subjects may be asked to give up to 8 additional blood samples to see if the level of antibodies changes over time.
| Condition | Intervention |
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Multiple Sclerosis Myasthenia Gravis Transverse Myelitis |
Other: Blood Draw |
| MedlinePlus related topics: | Cancer Multiple Sclerosis Myasthenia Gravis Neurologic Diseases |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | CCRC: Serum Auto-Antibodies in Neurological Disease |
5cc of serum will be obtained from patients with multiple sclerosis and other autoimmune and inflammatory diseases of the nervous system. Samples may be processed immediately or at a later time. Samples will be stored frozen in the freezer located in the Neuroscience building at Research Park in Davis, CA. Samples are identified with initials only.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|
Cohort 1
Subjects with multiple sclerosis and other autoimmune and inflammatory disease of the nervous system
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Other: Blood Draw
A 5cc sample of serum will be drawn from each subject. Only one blood draw is required, but up to 8 additional blood draws can be obtained.
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The purposes of the study are to determine the frequency of auto-antibodies to 1) heat shock proteins and 2) to other molecules including cytoskeletal proteins such as rapsyn in diseases of the nervous system.
5cc of serum will be obtained from patients with multiple sclerosis and other autoimmune and inflammatory diseases of the nervous system including myasthenia gravis and transverse myelitis and from patients with other neurological diseases. Standard methodology to assure safe handling of serum will be used. Diluted serum will be tested for specific reactivity with heat shock proteins (Sigma Chemical Co., St. Louis, MO) as well as with other antigens in a standard ELISA as well as immunoblot.
Rapsyn and other cytoskeletal proteins will be extracted from Torpedo californica electric organ by means of differential centrifugation followed by alkali extraction. For the ELISA, a standard titration curve will be obtained for a positive control serum as previously determined. Negative control sera will be obtained from individuals with other degenerative neurological diseases. Titers of test serum will be determined as the dilution that generates a positive result that is two standard deviations from the mean of the background. Positive ELISA results will be confirmed by immunoblot. Patients may be tested at one time point only. If the serum is positive for specific antibody binding, additional serum samples may be obtained and retested up to 8 more times approximately 3 months apart. Correlation with severity of clinical findings and specific antibody titer will be made. Severity of clinical findings will be determined by the neurological exam done by the investigator.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients 18 years and older with multiple sclerosis, myasthenia gravis and other autoimmune or inflammatory neurological illnesses will be selected for participation in this study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Janelle Butters, RN | 916-734-6276 | janelle.butters@ucdmc.ucdavis.edu |
| Contact: Molly Lindsay | 916-734-6213 | molly.lindsay@ucdmc.ucdavis.edu |
| United States, California | |||||
| University of California, Davis | Recruiting | ||||
| Sacramento, California, United States, 95817 | |||||
| Contact: Janelle Butters, RN 916-734-6276 janelle.butters@ucdmc.ucdavis.edu | |||||
| Contact: Molly Lindsay 916-734-6312 molly.lindsay@ucdmc.ucdavis.edu | |||||
| Principal Investigator: Mark Agius, MD | |||||
| University of California, Davis |
| Principal Investigator: | Mark Agius, MD | University of California, Davis |
More Information
| Responsible Party: | University of California, Davis ( Mark Agius, MD ) |
| Study ID Numbers: | 200210314 |
| First Received: | June 23, 2008 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00704626 |
| Health Authority: | United States: Institutional Review Board |
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