Autoimmunity in Sisters of Lupus Patients (SisSLE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Systemic Lupus Erythematosus |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Prospective |
| Official Title: | Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2) |
- 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 ] [ Designated as safety issue: No ]
- To understand the preclinical biological and immunological events that precede the development of systemic lupus [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Sisters who have a diagnosis of SLE
Sisters who have a diagnosis of SLE
|
|
Unaffected Sisters
Sisters of SLE patients who do not have a diagnosis of SLE
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 10 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Sisters: One sister must be diagnosed with Systemic Lupus Erythematous ( SLE ) by and including age 40 who has a sister(s) or half sister(s) not affected with SLE currently between the ages of 10 and 45 are being recruited nation wide through community and physician referrals.
Sister Diagnosed with SLE:
Inclusion Criteria:
- Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.
- Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify.
Exclusion Criteria:
If inclusion criteria above are met for the proband, there are no exclusions.
Sister who does not have SLE:
Inclusion Criteria:
- Female with a full or half sister who has been documented SLE that meets ACR criteria.
- Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
- Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
- Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet.
Exclusion Criteria:
If Sister meets inclusion criteria, there will be no exclusions.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Peter Gregersen, Principal Investigator, North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT01076101 History of Changes |
| Other Study ID Numbers: | 09-263, R01AI068759 |
| Study First Received: | February 24, 2010 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
|
SLE sister autoimmune disease |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013