ADVN Biomarker Registry Study

This study has been terminated.
(This study was combined into DAIT ADRN-02)
Sponsor:
Collaborator:
Atopic Dermatitis and Vaccinia Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00550316
First received: October 25, 2007
Last updated: April 1, 2014
Last verified: April 2014

October 25, 2007
April 1, 2014
May 2006
June 2015   (final data collection date for primary outcome measure)
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 ]
Not Provided
Not Provided
 
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
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

Participants with and without AD who meet the participation criteria

Atopic Dermatitis
Not Provided
  • 1
    Participants with AD who currently have or have had Eczema Herpeticum (EH)
  • 2
    African Americans and Caucasians of non-Hispanic lineage with AD who do not have and have never had EH
  • 3
    Participants with AD who currently have or have had Eczema Vaccinatum (EV)
  • 4
    Participants with AD who do not have and have never had EV despite receipt of the smallpox vaccination
  • 5
    Participants with AD and a currently active case of Molluscum Contagiosum (MC)
  • 6
    Participants without AD but who currently have an active case of MC
  • 7
    Healthy African Americans and Caucasians of non-Hispanic lineage without a history of AD, EH, EV, or MC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1099
June 2015
June 2015   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00550316
DAIT ADVN REG 03, Contract #: HHSN266200400033
No
National Institute of Allergy and Infectious Diseases (NIAID)
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)
April 2014

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