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Genetic Study of Lupus Patients and Their Families

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235378
First Posted: October 10, 2005
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation
  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 Oklahoma Medical Research Foundation:

Biospecimen Retention:   Samples With DNA
Blood

Enrollment: 2356
Study Start Date: July 1996
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235378


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Oklahoma Medical Research Foundation
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

Publications:

Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00235378     History of Changes
Other Study ID Numbers: R01AR043274 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Oklahoma Medical Research Foundation:
Lupus
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases