Serum Auto-Antibodies (SAA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mark Agius, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00704626
First received: June 23, 2008
Last updated: November 20, 2012
Last verified: November 2012
  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.

Please note that this study is conducted ONLY at UC Davis and that all participants must be seen in our clinic located in Sacramento, CA. Results of the testing performed in this study are not given to the participants. This study is not intended to treat or diagnose any condition.


Condition Intervention
Multiple Sclerosis
Myasthenia Gravis
Transverse Myelitis
Other: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CCRC: Serum Auto-Antibodies in Neurological Disease

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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: June 2015
Estimated Primary Completion Date: June 2015 (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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704626

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Mark Agius, MD
Investigators
Principal Investigator: Mark Agius, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Mark Agius, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00704626     History of Changes
Other Study ID Numbers: 200210314
Study First Received: June 23, 2008
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Multiple Sclerosis
Autoimmune disease
Inflammatory disease
Myasthenia Gravis
Transverse Myelitis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Myasthenia Gravis
Myelitis, Transverse
Myelitis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Spinal Cord Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014