Lupus Genetics Studies (LFRR)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was Recruiting

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

ClinicalTrials.gov Identifier:

NCT00071175

First received: October 14, 2003

Last updated: November 14, 2008

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2003

Last Updated Date

November 14, 2008

Start Date ^ICMJE

October 1995

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00071175 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lupus Genetics Studies

Official Title ^ICMJE

Lupus Genetic Studies; Lupus Family Registry & Repository

Brief Summary

The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.

Detailed Description

SLE is an often crippling and potentially fatal autoimmune disease that is nine times more prevalent in women than in men, and four times more likely to affect African American females than Caucasian females. It is suspected that a genetic predisposition along with environmental factors contribute to the clinical manifestation of SLE. The Lupus Genetics Studies consist of several familial SLE studies, including the Lupus Family Registry & Repository (LFRR, formerly known as the Lupus Multiplex Registry & Repository, or LMRR). The Lupus Studies enroll families of all ethnicities with one or more members diagnosed with systemic lupus to determine what genes contribute to the development of the disease.

Additionally, the Lupus Family Registry & Repository is the largest repository of its kind in North America. In addition to the research done on site, the Repository serves as a national resource for scientists interested in conducting research on SLE and families either simplex or multiplex for lupus. Data, serum samples, and DNA samples are available to researchers. By collecting families in which two or more living individuals have been diagnosed with SLE, the study is utilizing the genetic link between the affected family members to discover disease-associated genes.

Records will be requested from the patients' treating physicians to document various lupus symptoms and related problems. One-time blood samples will be collected from the patients as well as from certain family members and an unrelated volunteer. There is no cost to participate and the study pays for sample draws and shipping.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Family-Based
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

DNA, sera, plasma, cell lines

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with SLE Families with living members diagnosed with SLE

Condition ^ICMJE

Systemic Lupus Erythematosus

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

18000

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Families in which one or more living members have been diagnosed with systemic lupus erythematosus

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Recruiters

1-888-655-8787

lupus-recruiters@lupus.omrf.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00071175

Other Study ID Numbers ^ICMJE

NIAMS-103, AI24717, AR42460, AR049084, AR52253, AR62277

Has Data Monitoring Committee

Responsible Party

John B. Harley, MD, PhD; Principal Investigator, Oklahoma Medical Research Foundation

Study Sponsor ^ICMJE

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:

John B. Harley, MD, PhD

Member & Program Head, Arthritis and Immunology Research Program; Oklahoma Medical Research Foundation

Information Provided By

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Verification Date

November 2008

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

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