Autoimmunity in Sisters of Lupus Patients (SisSLE)
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|ClinicalTrials.gov Identifier: NCT01076101|
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 6, 2017
|Condition or disease|
|Systemic Lupus Erythematosus|
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that causes inflammation and is accompanied by the development of autoantibodies. The inflammation caused by SLE may affect the skin, joints, lungs, blood, kidneys and nervous system. The cause of SLE is unknown, but research has indicated that it is caused by a combination of genetic and environmental factors.
Autoimmune diseases often run in families. Close relatives of people with these diseases are at greater risk of developing the same or another autoimmune disease. The study is designed to determine several things: If sisters of people with SLE make the same antibodies that are present in people with SLE, whether or not environmental factors affect the chances of developing these antibodies and if so what these environmental factors may be, if the presence of these antibodies in healthy people leads to increased risk for the development of SLE.
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Participation is voluntary and participants can stop participating at any time.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||817 participants|
|Target Follow-Up Duration:||7 Years|
|Official Title:||Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
Sisters who have a diagnosis of SLE
Sisters who have a diagnosis of SLE
Sisters of SLE patients who do not have a diagnosis of SLE
- To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely [ Time Frame: 5 years ]
- To understand the preclinical biological and immunological events that precede the development of systemic lupus [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
We will use your DNA blood sample to study the function of genes and biomarkers and gain understanding of their role in protection against disease or the role they play in increasing the risk factors of developing lupus. No, you will not get test results since the information we gather is only useful for research and is not diagnostic. Participation in this study is not a substitute for regular medical care.
The information and blood sample that is collected for research will be analyzed for many years and it is not possible to know how long this analysis and follow-up will take. Therefore, participation allows the information and banking of your blood sample to be indefinite.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076101
|United States, New York|
|The Feinstein Institute for Medical Research|
|Manhasset, New York, United States, 11030|
|Principal Investigator:||Peter K Gregersen, MD||NorthShore -LIJ The Feinstein Institute for Medical Research|