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| Tracking Information | |||||
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| First Received Date ICMJE | October 25, 2007 | ||||
| Last Updated Date | May 26, 2009 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Successful creation of a useful database of clinical and diagnostic information [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Successful creation of a useful database of clinical and diagnostic information [ Time Frame: Throughout study ] | ||||
| Change History | Complete list of historical versions of study NCT00550316 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Identification and assessment of biomarkers of AD [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Identification and assessment of genetic markers of AD [ Time Frame: Throughout study ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ADVN Biomarker Registry Study | ||||
| Official Title ICMJE | ADVN Biomarker Registry Study | ||||
| Brief Summary | People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is known about the causes of AD. The purpose of this study is to create a registry of people both with and without AD. This registry will be used as a source of data to determine genetic markers for AD and also as a potential participant database for future studies. |
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| Detailed Description | AD is a chronic, inflammatory skin condition characterized by itching, flaking skin, and a tendency to acquire viral skin infections. The causes and complications of AD are not well understood. The purpose of this study is to establish a registry of people, both with AD and without AD, to help determine genetic markers of AD as well as to contact for participation in future AD studies. This study will consist of one visit at which the participant's complete medical history will be taken, and blood collection may occur. Participants may be contacted at a later date to participate in future AD studies. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Cross-Sectional | ||||
| Condition ICMJE | Atopic Dermatitis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| 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 | 1000 | ||||
| Estimated Completion Date | January 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Months to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00550316 | ||||
| Responsible Party | Associate Director, Clinical Research Program, DAIT/NIAID | ||||
| Study ID Numbers ICMJE | DAIT ADVN REG 03, Contract #: HHSN266200400033 | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | Atopic Dermatitis and Vaccinia Network | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | May 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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