ADVN Biomarker Registry Study - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Atopic Dermatitis and Vaccinia Network
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00550316

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:	Case Control, Cross-Sectional
Official Title:	ADVN Biomarker Registry Study

Resource links provided by NLM:

MedlinePlus related topics: Eczema

U.S. FDA Resources

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

Biospecimen Description:

Blood samples

Estimated Enrollment:	1000
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2010

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 participants with currently active or 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

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

Contacts

Contact: Judy Lairsmith

(303) 270-2413

lairsmithj@NJHealth.org

Locations

United States, California
Univeristy of California at San Diego	Recruiting
La Jolla, California, United States
Contact: Monika Gerber 858-657-8390 mogerber@ucsd.edu
Principal Investigator: Richard Gallo, MD, PhD
Sub-Investigator: Tissa Hata, MD
United States, Colorado
National Jewish Health	Recruiting
Denver, Colorado, United States
Contact: Judy Lairsmith 303-270-2413 lairsmithj@NJHealth.org
Principal Investigator: Donald Leung, MD, PhD
Sub-Investigator: Mark Boguniewicz, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States
Contact: Candrice R. Heath, MD 773-327-3326 cheath@childrensmemorial.org
Principal Investigator: Amy Paller, MD
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States
Contact: Candrice R. Heath, MD 773-327-3326 cheath@childrensmemorial.org
Principal Investigator: Amy Paller, MD
United States, Massachusetts
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States
Contact: Lisa Heughan 617-355-6127 lisa.heughan@childrens.harvard.edu
Principal Investigator: Lynda Schneider, MD
United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States
Contact: Lorianne Stubbs 585-275-0374 Lorianne_Stubbs@urmc.rochester.edu
Principal Investigator: Lisa Beck, MD
United States, Oregon
Oregon Health & Sciences University	Recruiting
Portland, Oregon, United States
Contact: Susan Tofte 503-494-6445 toftes@ohsu.edu
Principal Investigator: Jon Hanifin, MD, PhD
Sub-Investigator: Eric Simpson, MD

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Atopic Dermatitis and Vaccinia Network

Investigators

Principal Investigator:

Lisa Beck, MD

University of Rochester

More Information

Additional Information:

Click here for more information on the Atopic Dermatitis and Vaccinia Network This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers:	DAIT ADVN REG 03, Contract #: HHSN266200400033
Study First Received:	October 25, 2007
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00550316 History of Changes
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:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 25, 2009