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Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
94-AR-0066 |
Sponsoring Institute |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
Yes |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Systemic Lupus Erythematosus; |
Recruitment Keyword(s) |
Lupus Nephritis; |
Condition(s) |
Lupus Nephritis; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Patients 10 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include:
1. Electrocardiogram
2. 24-hour urine collection
3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.
4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.
5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm.
6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is removed, using a sharp cookie cutter-type instrument.
7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions.
8. Genetic studies-Collection of a blood sample for gene testing.
Patients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll.
Participating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing.
Eligibility
INCLUSION CRITERIA:Patients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient's permission to contact his/her relatives, as described in details in Section IV.H.
-SLE or suspected SLE established by ACR criteria
-Ability to give informed consent
-Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
-Ability of the patient or minor relative's parents to give informed consent
EXCLUSION CRITERIA:
-Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood if it interferes with interpretation of some Lupus studies.
-Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH
-Subjects considered as healthy volunteers will be disqualified if they have any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for
Criteria for Healthy Control Subjects
INCLUSION CRITERIA:
-Age 18 - 70 years
-Ability to give informed consent
EXCLUSION CRITERIA:
-Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Sarfaraz A. Hasni, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health BG 10-CRC RM 5-2340 MSC 1616 10 CENTER DR BETHESDA MD 20892-1616 (301) 451-1599 hasnisa@mail.nih.gov |
Elizabeth Joyal, R.N. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health Building 10 Room 3C709 10 Center Drive Bethesda, Maryland 20892 (301) 435-4489 ejoyal@mail.cc.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00001372
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