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
  Purpose

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.


Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: ADVN Biomarker Registry Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Successful creation of a useful database of clinical and diagnostic information [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification and assessment of biomarkers of AD [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples


Enrollment: 1099
Study Start Date: May 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   8 Months to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants with and without AD who meet the participation criteria

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550316

Locations
United States, California
Univeristy of California at San Diego
La Jolla, California, United States
United States, Colorado
National Jewish Health
Denver, Colorado, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States
United States, New York
University of Rochester Medical Center
Rochester, New York, United States
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States
Sponsors and Collaborators
Atopic Dermatitis and Vaccinia Network
Investigators
Principal Investigator: Lisa Beck, MD University of Rochester
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00550316     History of Changes
Other Study ID Numbers: DAIT ADVN REG 03, Contract #: HHSN266200400033
Study First Received: October 25, 2007
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Atopic Dermatitis
Eczema
Eczema Herpeticum
Molluscum Contagiousum
Herpes Simplex
Eczema Vaccinatum
Vaccinia

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 10, 2014