Recruitment status was Recruiting
|First Received Date ICMJE||December 16, 2003|
|Last Updated Date||May 8, 2009|
|Start Date ICMJE||September 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00074568 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|
|Brief Title ICMJE||Scleroderma Registry|
|Official Title ICMJE||Scleroderma Family Registry and DNA Repository|
Scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).
Scleroderma refers to a group of diseases that involve the abnormal growth of connective tissue, which supports the skin and internal organs. Scleroderma can affect the skin, making it hard and tight; it can also damage the blood vessels and internal organs such as the heart, lungs, and kidneys. Estimates for the number of people in the United States with the systemic (body-wide) form of scleroderma range from 40,000 to 165,000. The number of people with all scleroderma-related disorders is between 250,000 and 992,500.
Researchers believe that several factors interact to produce scleroderma, including abnormal immune activity, potential environmental triggers, and genetic makeup. Scleroderma is not passed on from parents to child, but certain genes may make a person more likely to develop the disease. The goals of this project are to identify the genes that influence disease susceptibility and expression in systemic scleroderma and to establish a repository of DNA, plasma, and serum samples from single case scleroderma families, multicase families, and healthy unrelated volunteers for the use of researchers interested in studying this disease.
Participants in the Registry will have a phone interview regarding disease characteristics and family history. Participants will be sent a blood kit to get a blood sample drawn locally for shipment to the Registry lab. Blood samples will be made available (anonymously) for studies by researchers around the country. In some cases, participants will be asked to sign a release of medical information so that medical records can be obtained to verify the diagnosis.
As of May 2009, this study is no longer enrolling family members.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Serum, Plasma, DNA
|Sampling Method||Non-Probability Sample|
Patients diagnosed with Systemic Sclerosis or family member of patients with systemic sclerosis
Healthy volunteer with no autoimmune disease and without a first degree relative with a systemic autoimmune disease.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||5000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00074568|
|Other Study ID Numbers ICMJE||NIAMS-108, NO1-AR-0-2251|
|Has Data Monitoring Committee||No|
|Responsible Party||Maureen D. Mayes MD MPH, University of Texas Health Science Center Houston|
|Study Sponsor ICMJE||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Collaborators ICMJE||The University of Texas Health Science Center, Houston|
|Information Provided By||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Verification Date||May 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP