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| Tracking Information | |||||
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| First Received Date ICMJE | October 14, 2003 | ||||
| Last Updated Date | March 31, 2009 | ||||
| Start Date ICMJE | September 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00071162 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetics of Fibromyalgia | ||||
| Official Title ICMJE | Fibromyalgia Family Study Registry | ||||
| Brief Summary | The Fibromyalgia Family Study identifies and collects blood samples from families with two or more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to identify genes that predispose people to FMS and/or symptoms related to FMS; identifying these genes may lead to a better understanding of the disease and more effective treatments. |
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| Detailed Description | FMS predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. The pathophysiological mechanisms underlying FMS are not clearly understood, but neuroendocrine factors seem to be of major importance. Studies of familial association suggest that genetic factors play a role in FMS. This study will establish patterns of genetic linkage in families with FMS. Participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. Measurements of serum serotonin and related compounds will also be obtained. To detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Family-Based, Retrospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Yunus MB, Khan MA, Rawlings KK, Green JR, Olson JM, Shah S. Genetic linkage analysis of multicase families with fibromyalgia syndrome. J Rheumatol. 1999 Feb;26(2):408-12. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 560 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00071162 | ||||
| Responsible Party | Sudha Iyengar, PhD, Case Western Reserve University | ||||
| Study ID Numbers ICMJE | NIAMS-100 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2009 | ||||
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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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