Autoimmunity in Sisters of Lupus Patients

NCT01076101 | Completed

• 2 other identifiers: 09-263R01AI068759
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; sister; autoimmune disease

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (1)

• To understand the preclinical biological and immunological events that precede the development of systemic lupus

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Sister who does not have SLE:
• 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.

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

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.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Peter K Gregersen, MD

  NorthShore -LIJ The Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2009
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)