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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
Publications:

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 July 28, 2014