- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00515047
Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis (Genetics)
Genetics of Atopic Dermatitis - Eczema Herpeticum
Studieoversikt
Status
Forhold
Detaljert beskrivelse
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. However, people with AD do not all develop the same infections. For example, some people with AD who receive the smallpox vaccine develop a life-threatening condition known as eczema vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the development of skin infections are due to differences in viral exposure, and instead due to differences in each individual's response to viruses. The purpose of this study is to determine the genetic pathways which are responsible for the development of viral skin infections in people with AD.
Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There will be only one clinical visit for this study at which blood and/or skin samples may be collected. The samples will then have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92037
- University of California at San Diego
-
-
Colorado
-
Denver, Colorado, Forente stater, 80206
- National Jewish Health
-
-
Illinois
-
Chicago, Illinois, Forente stater
- Northwestern University
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Chicago, Illinois, Forente stater
- Children's Memorial Hospital
-
-
Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Children's Hospital Boston
-
-
New York
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health & Sciences University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Enrollment in ADVN Biomarker Registry Study
- Non-Hispanic and only African American or only Caucasian race
- Parent or guardian willing to provide informed consent, if necessary
Exclusion Criteria:
- History of any systemic illness, excluding AD
- Participation of a first degree relative already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH+. More information on this criterion can be found in the protocol.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Eczema Herpeticum (EH)
Participants with AD who currently have or have had EH
|
Non-EH
Participants with AD who do not have and have never had EH
|
Healthy Controls
Healthy participants without a history of AD
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH
Tidsramme: Throughout Study
|
Throughout Study
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD participants and relevant control groups
Tidsramme: Throughout Study
|
Throughout Study
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lisa Beck, MD, University of Rochester
- Hovedetterforsker: Kathleen Barnes, PhD, Johns Hopkins Allergy and Asthma Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. doi: 10.1111/j.1365-2249.2005.02980.x.
- Kim BE, Leung DY, Streib JE, Kisich K, Boguniewicz M, Hamid QA, Howell MD. Macrophage inflammatory protein 3alpha deficiency in atopic dermatitis skin and role in innate immune response to vaccinia virus. J Allergy Clin Immunol. 2007 Feb;119(2):457-63. doi: 10.1016/j.jaci.2006.10.005. Epub 2006 Dec 4. Erratum In: J Allergy Clin Immunol. 2008 Nov;122(5):1007.. Kisich, Kevin [added].
- Porter CD, Muhlemann MF, Cream JJ, Archard LC. Molluscum contagiosum: characterization of viral DNA and clinical features. Epidemiol Infect. 1987 Oct;99(2):563-6. doi: 10.1017/s0950268800068072.
- Umene K, Yoshida M, Sakaoka H. Comparison of the association with eczema herpeticum in the two predominant genotypes of herpes simplex virus type 1. J Med Virol. 1996 Aug;49(4):329-32. doi: 10.1002/(SICI)1096-9071(199608)49:43.0.CO;2-5.
- Gao PS, Leung DY, Rafaels NM, Boguniewicz M, Hand T, Gao L, Hata TR, Schneider LC, Hanifin JM, Beaty TH, Beck LA, Weinberg A, Barnes KC. Genetic variants in interferon regulatory factor 2 (IRF2) are associated with atopic dermatitis and eczema herpeticum. J Invest Dermatol. 2012 Mar;132(3 Pt 1):650-7. doi: 10.1038/jid.2011.374. Epub 2011 Nov 24.
- Gao PS, Rafaels NM, Mu D, Hand T, Murray T, Boguniewicz M, Hata T, Schneider L, Hanifin JM, Gallo RL, Gao L, Beaty TH, Beck LA, Leung DY, Barnes KC. Genetic variants in thymic stromal lymphopoietin are associated with atopic dermatitis and eczema herpeticum. J Allergy Clin Immunol. 2010 Jun;125(6):1403-1407.e4. doi: 10.1016/j.jaci.2010.03.016. Epub 2010 May 13. No abstract available.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Virussykdommer
- Infeksjoner
- Sykdommer i immunsystemet
- Overfølsomhet, Umiddelbar
- Genetiske sykdommer, medfødte
- DNA-virusinfeksjoner
- Hudsykdommer, genetisk
- Hudsykdommer, smittsomme
- Overfølsomhet
- Hudsykdommer, viral
- Hudsykdommer, eksem
- Herpesviridae-infeksjoner
- Herpes Simplex
- Dermatitt
- Eksem
- Dermatitt, atopisk
- Kaposi Varicelliform utbrudd
Andre studie-ID-numre
- DAIT ADVN GENE 04
- HHSN266200400033
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