Registry for the Atopic Dermatitis Research Network
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01494142 |
|
Recruitment Status :
Completed
First Posted : December 16, 2011
Last Update Posted : September 19, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Atopic Dermatitis Eczema Herpeticum |
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 or why people with AD are more prone to infections. The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant database for future studies.
Study procedures will usually be completed in one visit to the clinic; however, participants may need to return for one or more additional visits to provide blood and skin swabs if they do not meet sampling criteria at the initial Screening Visit. A subset of participants from National Jewish Health may be asked to return to clinic for 2 additional visits approximately 7 and 14 days after the original sample collection for collection of skin swabs for assessment of antimicrobial activity. All participants may also be asked to return for an Unscheduled Visit to provide additional blood and/or skin swabs. Atopic Dermatitis with previous or current Eczema Herpeticum (ADEH+), Atopic Dermatitis with previous or current Eczema Vaccinatum (ADEV+) and Methicillin-Resistant S. Aureus (MRSA+) participants will be contacted every 6 months for the duration of the study.
Recruitment emphasis will include Non-Hispanic Caucasian, Non-Hispanic African American, and Mexican American since these constitute the three largest racial/ethnic populations according to the U.S. Census Bureau 2009 data; however, no racial/ethnic groups will be excluded. Our scientific rationale for targeting these three racial/ethnic groups is to ensure that we are able to recruit sufficient numbers of participants in each group to perform meaningful tests for genetic association.
| Study Type : | Observational |
| Actual Enrollment : | 3387 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Registry for the Atopic Dermatitis Research Network (ADRN-02) |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | February 7, 2018 |
| Actual Study Completion Date : | February 7, 2018 |
| Group/Cohort |
|---|
|
ADEH-Staph+
Atopic Dermatitis without a history of Eczema Herpeticum and with S. aureus skin colonization. A minimum of 1100 participants will be enrolled; we will target 500 Non-Hispanic Caucasian, 300 Non-Hispanic African American, and 300 Mexican American Caucasian ADEH-Staph+ participants. Although we will target these three groups, no racial/ethnic groups will be excluded.
|
|
ADEH-Staph-
Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization. A minimum of 1100 participants will be enrolled; we will target 500 Non-Hispanic Caucasian, 300 Non-Hispanic African American, and 300 Mexican American Caucasian ADEH-Staph- participants. Although we will target these three groups, no racial/ethnic groups will be excluded.
|
|
ADEH+
Atopic Dermatitis with previous or current Eczema Herpeticum.We will try to include a minimum of 150 Non-Hispanic Caucasian ADEH+ participants. ADEH+ participants of other racial/ethnic groups will not be excluded
|
|
ADEV+
Atopic Dermatitis with previous or current Eczema Vaccinatum. ADEV+ sub-phenotype is very rare so all eligible participants will be enrolled.
|
|
Non-atopic
Non-atopic healthy participants. A minimum of 250 non-atopic participants will be enrolled. Non-atopic participants will serve as a control group for the genetic, biomarker, Staph characterization, and microbiome studies.
|
- Genotype and sequence data from ADEH+ and ADEH- participants. [ Time Frame: Day 1 ]
- Genotype and sequence data from ADEH- participants with and without bacterial colonization with S. aureus. [ Time Frame: Day 1 ]
- Single Nucleotide Polymorphism (SNP) and Copy Number Variant (CNV) genotype data for candidate genes, including but not limited to Claudin-1 (CLDN1) and Filaggrin (FLG). [ Time Frame: Day 1 ]
- SNP genotype data for candidate genes, including but not limited to CLDN1 and FLG, validated in samples from an independent AD population. [ Time Frame: Day 1 ]
- Targeted deep resequencing of candidate genes, including but not limited to CLDN1. [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for antibiotic sensitivity [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for staphylococcal cassette chromosome (SCC) mec DNA elements. [ Time Frame: Day 1 ]
- Analysis of S. aureus isolates for expression of virulence or other factors. [ Time Frame: Day 1 ]
- Expression of biomarkers, including but not limited to serum biomarkers, among AD sub-phenotypes. [ Time Frame: Day 1 ]
- Analysis of microbial composition by 16S ribosomal Deoxyribonucleic Acid (rDNA) amplicon sequencing. [ Time Frame: Day 1 ]
- Analysis of DNA methylation profiles [ Time Frame: Day 1 ]
- Analysis of messenger Ribonucleic Acid (mRNA) expression profiles in whole blood samples. [ Time Frame: Day 1 ]
- Frequency of commensal Staphylococcus species producing antimicrobial activity [ Time Frame: Day 1 ]
Biospecimen Retention: Samples With DNA
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 8 Months to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
A minimum of 1100 ADEH-Staph+ participants and a minimum of 1100 ADEH-Staph- participants 3-80 years of age will be enrolled. In addition, ADEH+, ADEV+, and Non-atopic participants 8 months to 80 years of age will be enrolled.
It is unknown whether Staph colonization status will change as younger participants get older. For this reason, the lower age limit for inclusion of ADEH- participants is 3 years rather than 8 months to ensure that characterization of their Staph+ vs. Staph- state is more accurate
Inclusion Criteria:
Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible.
- ADEH+ and Non-atopic males and females ages 8 months to 80 years, inclusive, at the time of Enrollment, and ADEH- males and females ages 3 years to 80 years, inclusive, at the time of Enrollment.
- Who are willing to sign the informed consent form or whose parent or legal guardian is willing to sign the informed consent form (age appropriate) prior to initiation of any study procedures.
- Who are willing to sign the assent form, if age appropriate.
- Who meet criteria for one of the diagnostic groups (ADEH-Staph+, ADEH-Staph-, ADEH+, ADEV+, Non-atopic) as defined in the ADRN Standard Diagnostic Criteria and the Staphylococcus aureus Colonization Criteria.
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for enrollment.
- Who have an active systemic malignancy; uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary.
- Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- Who have a history of systemic immunological illness (e.g., immunodeficiency disorders such as human immunodeficiency virus [HIV] or lupus erythematosus) other than the condition being studied.
- Who have a first degree relative already enrolled in the study.
- Who are determined not to be eligible in the opinion of the Investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494142
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | |
| New York, New York, United States, 10029 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Lisa Beck, MD | University of Rochester | |
| Study Chair: | Kathleen Barnes, PhD | Johns Hopkins Asthma and Allergy Center |
Publications of Results:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01494142 |
| Obsolete Identifiers: | NCT00550316 |
| Other Study ID Numbers: |
DAIT ADRN-02 |
| First Posted: | December 16, 2011 Key Record Dates |
| Last Update Posted: | September 19, 2018 |
| Last Verified: | September 2018 |
|
Registry Atopic Dermatitis Eczema Herpeticum GWAS Staphylococcus aureus |
|
Kaposi Varicelliform Eruption Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Infections Skin Diseases, Viral Skin Diseases, Infectious |