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CCRC: Serum Auto-Antibodies in Neurological Disease


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Sclerosis, Myasthenia Gravis, Transverse Myelitis

Thank you

Trial Information

CCRC: Serum Auto-Antibodies in Neurological Disease


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.


Inclusion Criteria:



- 18 years or older

- Diagnosis of multiple sclerosis, myasthenia gravis, or other autoimmune or
inflammatory neurological disease

Exclusion Criteria:

- inability to give informed consent

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Mark Agius, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Institutional Review Board

Study ID:

200210314

NCT ID:

NCT00704626

Start Date:

January 2002

Completion Date:

June 2015

Related Keywords:

  • Multiple Sclerosis
  • Myasthenia Gravis
  • Transverse Myelitis
  • Multiple Sclerosis
  • Autoimmune disease
  • Inflammatory disease
  • Myasthenia Gravis
  • Transverse Myelitis
  • Multiple Sclerosis
  • Myasthenia Gravis
  • Myelitis
  • Myelitis, Transverse
  • Sclerosis

Name

Location

University of California, DavisSacramento, California  95818