Genetic Study of Lupus Patients and Their Families
Recruitment status was Recruiting
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| First Received Date ICMJE | October 6, 2005 | ||||||||
| Last Updated Date | March 11, 2008 | ||||||||
| Start Date ICMJE | July 1996 | ||||||||
| Estimated Primary Completion Date | June 2011 (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 NCT00235378 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 | Genetic Study of Lupus Patients and Their Families | ||||||||
| Official Title ICMJE | Gene Mapping in Women With SLE | ||||||||
| Brief Summary | 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants include SLE patients, their unaffected family members, and healthy controls. |
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| Condition ICMJE | Systemic Lupus Erythematosus | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 5000 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00235378 | ||||||||
| Other Study ID Numbers ICMJE | R01 AR43274, R01-AR/AI-43274 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Timothy Behrens, MD, University of Minnesota | ||||||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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