Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001372
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
1999-11-03
Brief Title:
Study of Systemic Lupus Erythematosus
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus SLE
Status:
RECRUITING
Status Verified Date:
2024-09-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol will evaluate patients with systemic lupus erythematosus SLE and their relatives to learn more about how the disease develops and changes over time It will also study genetic factors that make a person susceptible to SLE
Patients 3 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 14 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
Patients 3 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 14 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
Detailed Description:
This research protocol will evaluate subjects with systemic lupus erythematosus SLE and their relatives to study the pathogenesis and natural history of the disease and the mechanisms leading to enhanced organ damage Patients will be evaluated by a history and physical examination and routine laboratory studies will be obtained as needed to assess disease activity or complications of the disease and to monitor for drug-related toxicities Blood skin or urine specimens may be requested for research purposes including genetic studies In addition a subset of these patients will undergo several tests to understand the pathogenic changes affecting their blood vessels Patients who are eligible for other research protocols will be offered the opportunity to participate in these studies by signed informed consent Any medical care recommended or provided to the patient will be consistent with routine standards of practice and provided in consultation with the patient s referring physician Blood and urine samples and cardiovascular testing will also be collected or applied to from healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-AR-0066 | None | None | None |