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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 29, 2003 | ||||||||
| Last Updated Date | June 17, 2009 | ||||||||
| Start Date ICMJE | November 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00069589 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alopecia Areata Registry | ||||||||
| Official Title ICMJE | Alopecia Areata Registry and Immunogenetic Mechanisms | ||||||||
| Brief Summary | Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata. |
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| Detailed Description | Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question. Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3100 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00069589 | ||||||||
| Responsible Party | Madeleine Duvic, M.D. Principle Investigator, University of Texas, M.D. Anderson Cancer Center | ||||||||
| Study ID Numbers ICMJE | NIAMS-097, HHSN268200682279C | ||||||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators ICMJE | M.D. Anderson Cancer Center | ||||||||
| 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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