Genetic Study of Lupus Patients and Their Families

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

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

Sponsor:

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00235378

First received: October 6, 2005

Last updated: March 11, 2008

Last verified: March 2008

History of Changes

Purpose

The purpose of this study is to perform genetic testing in and to collect information from families affected by lupus in order to identify the genetic factors associated with systemic lupus erythematosus (SLE).

Condition
Systemic Lupus Erythematosus

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Gene Mapping in Women With SLE

Resource links provided by NLM:

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention: Samples With DNA

Blood

Estimated Enrollment:	5000
Study Start Date:	July 1996
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 SLE patients
2 Unaffected family members of SLE patients
3 Control participants

Detailed Description:

Little is known about the genetic factors that predispose people to developing SLE. Genes in patients with SLE may provide clues about SLE's pathogenesis. This study will compare genes from SLE patients, their unaffected family members, and control participants. Travel to the study site is not required.

In this study, blood samples will be collected from people diagnosed with SLE, their unaffected family members, and condition-matched controls. Participants will be asked questions about their health and will provide a small blood sample. Participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. Study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Participants include SLE patients, their unaffected family members, and healthy controls.

Criteria

Inclusion Criteria:

Diagnosis of SLE OR a family member of participant diagnosed with SLE

Exclusion Criteria:

Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235378

Contacts

Contact: Angie Simonson

1-800-515-8787

recruiter@lupusstudy.org

Locations

United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Angie Simonson 800-515-8787 recruiting@lupusstudy.org
Principal Investigator: Timothy W. Behrens, MD

Sponsors and Collaborators

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

Investigators

Principal Investigator:	Timothy W. Behrens, MD	University of Minnesota - Clinical and Translational Science Institute
Principal Investigator:	Patrick Gaffney	University of Minnesota - Clinical and Translational Science Institute

More Information

Additional Information:

Click here for the Genetics of Systemic Lupus Erythematosus Family Study Web site This link exits the ClinicalTrials.gov site

Publications:

Baechler EC, Batliwalla FM, Karypis G, Gaffney PM, Ortmann WA, Espe KJ, Shark KB, Grande WJ, Hughes KM, Kapur V, Gregersen PK, Behrens TW. Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2610-5. Epub 2003 Feb 25.

Gillett CD, Langefeld CD, Williams AH, Ortmann WA, Graham RR, Rodine PR, Selby SA, Gaffney PM, Behrens TW, Moser KL. Fine mapping chromosome 16q12 in a collection of 231 systemic lupus erythematosus sibpair and multiplex families. Genes Immun. 2005 Feb;6(1):19-23.

Graham RR, Ortmann WA, Langefeld CD, Jawaheer D, Selby SA, Rodine PR, Baechler EC, Rohlf KE, Shark KB, Espe KJ, Green LE, Nair RP, Stuart PE, Elder JT, King RA, Moser KL, Gaffney PM, Bugawan TL, Erlich HA, Rich SS, Gregersen PK, Behrens TW. Visualizing human leukocyte antigen class II risk haplotypes in human systemic lupus erythematosus. Am J Hum Genet. 2002 Sep;71(3):543-53. Epub 2002 Jul 26.

Kyogoku C, Langefeld CD, Ortmann WA, Lee A, Selby S, Carlton VE, Chang M, Ramos P, Baechler EC, Batliwalla FM, Novitzke J, Williams AH, Gillett C, Rodine P, Graham RR, Ardlie KG, Gaffney PM, Moser KL, Petri M, Begovich AB, Gregersen PK, Behrens TW. Genetic association of the R620W polymorphism of protein tyrosine phosphatase PTPN22 with human SLE. Am J Hum Genet. 2004 Sep;75(3):504-7. Epub 2004 Jul 23.

Wakeland EK, Liu K, Graham RR, Behrens TW. Delineating the genetic basis of systemic lupus erythematosus. Immunity. 2001 Sep;15(3):397-408. Review.

Responsible Party:	Timothy Behrens, MD, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00235378 History of Changes
Other Study ID Numbers:	R01 AR43274, R01-AR/AI-43274
Study First Received:	October 6, 2005
Last Updated:	March 11, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Lupus
SLE

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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