Autoimmunity in Sisters of Lupus Patients (SisSLE)

• ClinicalTrials.gov Identifier: NCT01076101
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: February 6, 2017
• Sponsor: Northwell Health
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Peter Gregersen, Northwell Health

Tracking Information

• First Submitted Date: February 24, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: February 6, 2017
• Study Start Date: February 2009
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 24, 2010): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 24, 2010): To understand the preclinical biological and immunological events that precede the development of systemic lupus [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autoimmunity in Sisters of Lupus Patients
• Official Title: Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)
• Brief Summary: 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.

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Family-Based; Time Perspective: Prospective
• Target Follow-Up Duration: 7 Years

Biospecimen

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.

• Sampling Method: Probability Sample
• Study Population: 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.
• Condition: Systemic Lupus Erythematosus
• Intervention: Not Provided

Study 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2017): 817
• Original Estimated Enrollment (submitted: February 24, 2010): 800
• Actual Study Completion Date: December 31, 2016
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 10 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01076101
• Other Study ID Numbers: 09-263; R01AI068759 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Peter Gregersen, Northwell Health
• Study Sponsor: Northwell Health
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Peter K Gregersen, MD; NorthShore -LIJ The Feinstein Institute for Medical Research

• PRS Account: Northwell Health
• Verification Date: February 2017