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Autoimmunity in Sisters of Lupus Patients (SisSLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gregersen, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01076101
First received: February 24, 2010
Last updated: June 10, 2014
Last verified: June 2014

February 24, 2010
June 10, 2014
December 2009
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01076101 on ClinicalTrials.gov Archive Site
To understand the preclinical biological and immunological events that precede the development of systemic lupus [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Autoimmunity in Sisters of Lupus Patients
Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)

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.

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.

Observational [Patient Registry]
Observational Model: Family-Based
Time Perspective: Prospective
7 Years
Retention:   Samples With DNA
Description:

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.

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.

Systemic Lupus Erythematosus
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
December 2016
December 2016   (final data collection date for primary outcome measure)

Sister Diagnosed with SLE:

Inclusion Criteria:

  1. Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.
  2. 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:

  1. Female with a full or half sister who has been documented SLE that meets ACR criteria.
  2. Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
  3. Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
  4. 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.

Female
10 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01076101
09-263, R01AI068759
No
Peter Gregersen, North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Peter K Gregersen, MD NorthShore -LIJ The Feinstein Institute for Medical Research
North Shore Long Island Jewish Health System
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP