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ADVN Biomarker Registry Study
This study is currently recruiting participants.
Study NCT00550316   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: October 25, 2007   Last Updated: May 26, 2009   History of Changes

October 25, 2007
May 26, 2009
May 2006
 
Successful creation of a useful database of clinical and diagnostic information [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Successful creation of a useful database of clinical and diagnostic information [ Time Frame: Throughout study ]
Complete list of historical versions of study NCT00550316 on ClinicalTrials.gov Archive Site
Identification and assessment of biomarkers of AD [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Identification and assessment of genetic markers of AD [ Time Frame: Throughout study ]
 
ADVN Biomarker Registry Study
ADVN Biomarker Registry Study

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.

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.

 
Observational
Case Control, Cross-Sectional
Atopic Dermatitis
 
  • Participants with AD who currently have or have had Eczema Herpeticum (EH)
  • African Americans and Caucasians of non-Hispanic lineage with AD who do not have and have never had EH
  • Participants with AD who currently have or have had Eczema Vaccinatum (EV)
  • Participants with AD who do not have and have never had EV despite receipt of the smallpox vaccination
  • Participants with AD and a currently active case of Molluscum Contagiosum (MC)
  • Participants without AD but who currently have an active case of MC
  • Healthy participants with currently active or history of AD, EH, EV, or MC
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
January 2010
 

Inclusion Criteria:

  • Meet criteria for one of the AD groups or for healthy volunteer status groups. More information on this criterion can be found in the protocol.
  • Must be non-Hispanic, African American or Caucasian for participation in some groups. See information in Groups above for more information
  • Residing in the United States
  • Parent or legal guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Has atopy but lacks stringent AD features (only presumptive diagnosis of AD)
  • History of any systemic illness other than AD
  • Autoimmune or immunodeficiency disease
  • Active systemic malignancy. Participants with uncomplicated non-melanoma skin cancer are not excluded.
  • Any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous disease, psoriasis, cutaneous T-cell lymphoma).
  • Investigational research agents within 30 days prior to study entry
Both
8 Months to 80 Years
Yes
Contact: Judy Lairsmith (303) 270-2413 lairsmithj@NJHealth.org
United States
 
NCT00550316
Associate Director, Clinical Research Program, DAIT/NIAID
DAIT ADVN REG 03, Contract #: HHSN266200400033
National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis and Vaccinia Network
Principal Investigator: Lisa Beck, MD University of Rochester
National Institute of Allergy and Infectious Diseases (NIAID)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP