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| Descriptive Information Fields | |||||||||
| Brief Title † | Serum Auto-Antibodies | ||||||||
| Official Title † | CCRC: Serum Auto-Antibodies in Neurological Disease | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Multiple Sclerosis Myasthenia Gravis Transverse Myelitis |
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| Intervention † | Other: Blood Draw | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 120 | ||||||||
| Start Date † | January 2002 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00704626 | ||||||||
| Organization ID | 200210314 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of California, Davis | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of California, Davis | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | June 23, 2008 | ||||||||
| Last Updated Date | June 23, 2008 | ||||||||
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