To collect and store a serum sample of each patient that is referred to the Leiden University Medical Centre for evaluation of neuropsychiatric symptoms in SLE.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Not applicable
Secondary outcome
Not applicable
Background summary
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by
the presence of autoantibodies. Up to 80 percent of patients with SLE develop
neurological or psychiatric symptoms. These symptoms can be the consequence of
primary SLE involvement of the brain (primary NPSLE), be the consequence of
secondary, SLE-related causes such as side effects of drugs or infections
(secondary NPSLE) or have no relation with SLE. Symptoms are diverse and there
is no gold standard to diagnose NPSLE, it is still a clinical diagnosis "per
exclusionem". Pathogenesis in primary NPSLE is largely unclear, but
autoantibodies and a breach in the integrity of the blood-brain-barrier seem to
play a role.
The department of Rheumatolgy of the Leiden University Medical Centre is a
tertiary referral centre for patients with neuropsychiatric symptoms in SLE.
In September 2007, a specialized outpatient clinic for neuropsychiatric SLE
will start in the LUMC. In a multidisciplinary setting, patients referred from
other hospitals with possible NPSLE, will be evaluated in one day via the
Ambulant Department of Rheumatology (Sole Mio), by a neurologist, psychiatrist,
vascular internist and rheumatologist. They will undergo neuropsychological
testing, MRI scan of the brain (including quantitative MRI) and laboratory
tests. After 2 weeks a multidisciplinary meeting is organized and patients
visit the outpatient clinic to discuss the results.
Data of all NPSLE patients (clinical, laboratory and radiological) will be
registered in a database to be able to describe this population in the future.
To enable future research, serum will be stored.
Study objective
To collect and store a serum sample of each patient that is referred to the
Leiden University Medical Centre for evaluation of neuropsychiatric symptoms in
SLE.
Study design
After informed consent, one bloodsample (10 ml) is drawn by a nurse of the
Ambulant Department of Rheumatology (Sole Mio) during routine blood collection
neccessary for the evaluation of neuropsychiatric SLE. No additional punction
is needed.
Serum samples are coded and stored at -70° in the laboratory of the department
of Rheumatology, Leiden University Medical Centre. Serum samples will be stored
during 15 years.
Study burden and risks
None
Postbus 9600
2300 RC Leiden
Nederland
Postbus 9600
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Systemic Lupus Erythematosus
neuropsychiatric symptoms
Exclusion criteria
no SLE
no neuropsychiatric symptoms
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL18844.058.07 |