Serum Auto-Antibodies in Neurological Diseases

NCT00704626 | Enrolling By Invitation

• 1 other identifier: 215828
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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. Any additional blood draws would be performed at regularly scheduled clinic visits. There would be at least 3 months between blood draws over a period of up to 3 years, if requested by the physician. Depending on your diagnosis, the physician may also request the collection of mouth (buccal) cells. This takes about one minute and is painless. The cells are collected by swishing a swab around your mouth. This cheek swab would be done with each blood draw. 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.

Conditions

Multiple Sclerosis; Myasthenia Gravis; Transverse Myelitis

Keywords

Multiple Sclerosis; Autoimmune disease; Inflammatory disease; Myasthenia Gravis; Transverse Myelitis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (1)

Cohort 1

Subjects with multiple sclerosis and other autoimmune and inflammatory disease of the nervous system

Other: Blood Draw; Other: Cheek swab

Interventions

Blood Draw OTHER

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.

Cohort 1

Cheek swab OTHER

A swab will be swished around the inside of the mouth to collect mouth (buccal) cells. This will be done with each blood draw.

Also known as: Buccal swab

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• Diagnosis of multiple sclerosis, myasthenia gravis, or other autoimmune or inflammatory neurological disease

You may not qualify if:

• inability to give informed consent

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

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.

MeSH Terms

Conditions

Multiple Sclerosis; Myasthenia Gravis; Myelitis, Transverse; Autoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Myelitis; Central Nervous System Infections; Infections; Central Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Richman, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: January 1, 2002
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)