ID

45119

Beschreibung

Principal Investigator: Julia Segre, PhD, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA MeSH: Dermatitis, Atopic,Job's Syndrome,Wiskott-Aldrich Syndrome https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000266 The NIH Intramural Skin Microbiome Consortium (NISMC) is a collaboration of investigators with primary expertise in genomics, bioinformatics, large-scale DNA sequencing, dermatology, immunology, allergy, infectious disease, and clinical microbiology. Atopic dermatitis (AD, "eczema") is a chronic relapsing skin disorder that affects ~15% of U.S. children and is associated with $1 billion of medical costs annually. AD is characterized by dry, itchy skin, infiltrated with immune cells. Colonization by Staphylococcus aureus (S. aureus) is ten-fold more common in AD patients and is associated with disease flares. We hypothesize that, in addition to S. aureus, AD may also be associated with additional novel microbes and/or selective shifts of commensal microbes that are relevant to disease progression. The NISMC seeks to define the microbiota that resides in and on the skin and nares of three patient groups, all of whom have eczematous lesions and are currently seen at the NIH Clinical Center: (1) AD patients; (2) Wiskott-Aldrich syndrome (WAS) patients; and (3) Hyper IgE syndrome (HIES) syndrome patients. Examination of the microbiome of patients with WAS or HIES syndromes, both rare immunodeficiencies, will advance our understanding of how an individual's immune system shapes their cutaneous microbial community. We are performing a prospective longitudinal study that follows these groups of patient thorough the cycles of eczema flares, ascertaining clinical data and samples at each stage.

Link

https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000266

Stichworte

Versionen (3)
  1. 10.09.22 10.09.22 - Simon Heim
  2. 12.10.22 12.10.22 - Adrian Schulz
  3. 29.01.25 29.01.25 - Akane Nishihara
Rechteinhaber

Julia Segre, PhD, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA

Hochgeladen am

10. September 2022

DOI

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Lizenz

Creative Commons BY 4.0
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dbGaP phs000266 Skin Microbiome in Disease States: Atopic Dermatitis and Immunodeficiency

Englisch

Eligibility Criteria

6 Formulare  
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

*Inclusion Criteria for AD/HIES/WAS patients (unless specified otherwise):*
Beschreibung

Inclusion Criteria for AD/HIES/WAS patients (unless specified otherwise

Datentyp

boolean

Males or females 3 - 40 years of age. Minimum age of 3 enriches for patients that have active AD and are statistically less likely to resolve during this longitudinal study. Maximum age of 40 is to reduce chance of recruiting patients with age-related changes in skin.
Beschreibung

Males or females 3 - 40 years of age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0079399
UMLS CUI [1,3]
C0001779
AD patients: Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party's Diagnostic Criteria for Atopic Dermatitis. (Reference: Williams HC, Burney PG, Pembroke AC, et al: The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. III. Independent hospital validation. Br J Dermatol 131:406-16, 1994). Included in attachments.
Beschreibung

Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0011615
UMLS CUI [1,4]
C0041700
UMLS CUI [1,5]
C0043227
UMLS CUI [1,6]
C1518904
UMLS CUI [1,7]
C0679228
HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous dermatitis.
Beschreibung

HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous dermatitis.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C3279428
UMLS CUI [1,3]
C0043194
UMLS CUI [1,4]
C0011900
UMLS CUI [1,5]
C0026882
UMLS CUI [1,6]
C0011603
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C3279428
UMLS CUI [2,3]
C0043194
UMLS CUI [2,4]
C0011900
UMLS CUI [2,5]
C0026882
UMLS CUI [2,6]
C1298908
UMLS CUI [2,7]
C0011603
AD patients: SCORAD (SCORing Atopic Dermatitis) score of ≥ 25 indicating AD severity of moderate to severe. Included in appendix. (Reference: Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31.) Included in attachments.
Beschreibung

AD patients: SCORAD more then 25

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011615
UMLS CUI [1,3]
C0011900
UMLS CUI [1,4]
C0449820
UMLS CUI [1,5]
C0871208
UMLS CUI [1,6]
C0205081
UMLS CUI [1,7]
C0205082
AD patients: At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.
Beschreibung

AD patients: At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011615
UMLS CUI [1,3]
C0449642
UMLS CUI [1,4]
C0230436
UMLS CUI [1,5]
C2986546
UMLS CUI [1,6]
C1301880
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0011615
UMLS CUI [2,3]
C0449642
UMLS CUI [2,4]
C0446523
UMLS CUI [2,5]
C2986546
UMLS CUI [2,6]
C1301880
6. Must have a primary care professional who will continue care/evaluation in tandem with the protocol to whom information can be communicated.
Beschreibung

Must have a primary care professional who will continue care/evaluation in tandem with the protocol to whom information can be communicated.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0033131
UMLS CUI [1,4]
C0549178
UMLS CUI [1,5]
C0017313
UMLS CUI [1,6]
C2348563
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0033131
UMLS CUI [2,3]
C0009452
UMLS CUI [2,4]
C1955348
UMLS CUI [2,5]
C1508263
*Exclusion Criteria for AD/HIES/WAS patients:*
Beschreibung

Exclusion Criteria for AD/HIES/WAS patients

Datentyp

boolean

Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
Beschreibung

Subjects with unstable or uncontrolled medical conditions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205476
UMLS CUI [1,4]
C0035647
UMLS CUI [1,5]
C1514873
UMLS CUI [1,6]
C0019993
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C1444637
UMLS CUI [2,4]
C0439231
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
Beschreibung

Subjects receiving or planning to receivetreatment; 7 days or 5 half-lives of initiating this protocol.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0031765
UMLS CUI [1,5]
C0003250
UMLS CUI [1,6]
C0021079
UMLS CUI [1,7]
C1442452
UMLS CUI [1,8]
C0808070
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0013230
UMLS CUI [2,5]
C0031765
UMLS CUI [2,6]
C0003250
UMLS CUI [2,7]
C0021079
UMLS CUI [2,8]
C1442452
UMLS CUI [2,9]
C0808070
AD patients: Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for 8805; 7 days to small areas of skin intended for sampling. (Topical therapies for AD may be continued to non-adjacent, non-target sites.)
Beschreibung

AD patients: Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for more than 7 days to small areas of skin intended for sampling.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0011615
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C1512900
UMLS CUI [1,5]
C0087111
UMLS CUI [1,6]
C3540704
UMLS CUI [1,7]
C1442452
UMLS CUI [1,8]
C0332152
UMLS CUI [1,9]
C1302413
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0011615
UMLS CUI [2,3]
C1299582
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0087111
UMLS CUI [2,6]
C2825233
UMLS CUI [2,7]
C1442452
UMLS CUI [2,8]
C0332152
UMLS CUI [2,9]
C1302413
UMLS CUI [3,1]
C0680251
UMLS CUI [3,2]
C0011615
UMLS CUI [3,3]
C1299582
UMLS CUI [3,4]
C1512900
UMLS CUI [3,5]
C0087111
UMLS CUI [3,6]
C1522168
UMLS CUI [3,7]
C0038317
UMLS CUI [3,8]
C1442452
UMLS CUI [3,9]
C0332152
UMLS CUI [3,10]
C1302413
UMLS CUI [4,1]
C0680251
UMLS CUI [4,2]
C0011615
UMLS CUI [4,3]
C1299582
UMLS CUI [4,4]
C1512900
UMLS CUI [4,5]
C0087111
UMLS CUI [4,6]
C1562036
UMLS CUI [4,7]
C1442452
UMLS CUI [4,8]
C0332152
UMLS CUI [4,9]
C1302413
AD patients: Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
Beschreibung

AD patients with underlying immunodeficiency, either as primary disease or secondary to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0011615
UMLS CUI [1,3]
C0277554
UMLS CUI [1,4]
C0021051
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0011615
UMLS CUI [2,3]
C0439669
UMLS CUI [2,4]
C0021051
WAS/HIES patients: unable to remain off topical steroids and emollients (skin sampling sites only) for at least 24 hours prior to skin sampling. HIES/WAS patients will not be taken off their systemic (oral) antibiotics or systemic (oral) steroids. (Topical therapies may be continued to non-adjacent, non-target sites.)
Beschreibung

WAS/HIES patients: unable to remain off topical steroids and emollients (skin sampling sites only) for at least 24 hours prior to skin sampling.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0043194
UMLS CUI [1,3]
C3887645
UMLS CUI [1,4]
C1299582
UMLS CUI [1,5]
C1518544
UMLS CUI [1,6]
C1706203
UMLS CUI [1,7]
C0013983
UMLS CUI [1,8]
C1123023
UMLS CUI [1,9]
C0870078
UMLS CUI [1,10]
C2825164
UMLS CUI [1,11]
C1524031
UMLS CUI [1,12]
C1442770
Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.
Beschreibung

Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2827774
UMLS CUI [1,3]
C3665472
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C0680251
UMLS CUI [3,2]
C2827774
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C0006826
UMLS CUI [4,1]
C0680251
UMLS CUI [4,2]
C0279134
UMLS CUI [4,3]
C0006826
Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
Beschreibung

Subject with a chronic disease requiring treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
*Inclusion Criteria for Healthy Volunteers and Age Matched Controls:*
Beschreibung

Inclusion Criteria for Healthy Volunteers and Age Matched Controls

Datentyp

boolean

Males or females 3 - 40 years of age.
Beschreibung

Males or females 3 - 40 years of age.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0079399
UMLS CUI [1,4]
C0001779
Interval visits and age of controls must match enrolled AD patients.
Beschreibung

Interval visits and age of controls must match enrolled AD patients.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0001779
UMLS CUI [1,4]
C0545082
UMLS CUI [1,5]
C1272706
UMLS CUI [1,6]
C0439089
UMLS CUI [1,7]
C0030705
UMLS CUI [1,8]
C0011615
*Exclusion Criteria for Healthy Volunteers and Age Matched Controls:*
Beschreibung

Exclusion Criteria for Healthy Volunteers and Age Matched Controls

Datentyp

boolean

Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
Beschreibung

Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0443343
UMLS CUI [1,5]
C0035647
UMLS CUI [1,6]
C1514873
UMLS CUI [1,7]
C0019993
UMLS CUI [2,1]
C0009932
UMLS CUI [2,2]
C0680251
UMLS CUI [2,3]
C3843040
UMLS CUI [2,4]
C0443343
UMLS CUI [2,5]
C0019993
UMLS CUI [2,6]
C1444637
UMLS CUI [2,7]
C0205447
UMLS CUI [2,8]
C0439231
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants for more than 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
Beschreibung

Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
UMLS CUI [2,3]
C1301732
UMLS CUI [2,4]
C0087111
UMLS CUI [2,5]
C0013230
UMLS CUI [3,1]
C0680251
UMLS CUI [3,2]
C0009932
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0031765
UMLS CUI [3,5]
C0041625
UMLS CUI [4,1]
C0680251
UMLS CUI [4,2]
C0009932
UMLS CUI [4,3]
C1301732
UMLS CUI [4,4]
C0087111
UMLS CUI [4,5]
C0031765
UMLS CUI [4,6]
C0041625
UMLS CUI [5,1]
C0680251
UMLS CUI [5,2]
C0009932
UMLS CUI [5,3]
C0087111
UMLS CUI [5,4]
C0021079
UMLS CUI [6,1]
C0680251
UMLS CUI [6,2]
C0009932
UMLS CUI [6,3]
C1301732
UMLS CUI [6,4]
C0087111
UMLS CUI [6,5]
C0021079
UMLS CUI [7,1]
C0680251
UMLS CUI [7,2]
C0009932
UMLS CUI [7,3]
C0087111
UMLS CUI [7,4]
C0003250
UMLS CUI [8,1]
C0680251
UMLS CUI [8,2]
C0009932
UMLS CUI [8,3]
C1301732
UMLS CUI [8,4]
C0087111
UMLS CUI [8,5]
C0003250
Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.
Beschreibung

Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C1512900
UMLS CUI [1,5]
C0087111
UMLS CUI [1,6]
C3540704
UMLS CUI [1,7]
C1442452
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
UMLS CUI [2,3]
C1299582
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0087111
UMLS CUI [2,6]
C0442027
UMLS CUI [2,7]
C2825233
UMLS CUI [2,8]
C1442452
Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
Beschreibung

Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0277554
UMLS CUI [1,4]
C0021051
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
UMLS CUI [2,3]
C0439669
UMLS CUI [2,4]
C0021051
Subjects who are currently or have previously received treatment with chemotherapy or radiation.
Beschreibung

Subjects who are currently or have previously received treatment with chemotherapy or radiation.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1522449
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
UMLS CUI [2,3]
C1514463
UMLS CUI [2,4]
C1522449
UMLS CUI [3,1]
C0680251
UMLS CUI [3,2]
C0009932
UMLS CUI [3,3]
C0392920
UMLS CUI [4,1]
C0680251
UMLS CUI [4,2]
C0009932
UMLS CUI [4,3]
C1514457
Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
Beschreibung

Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0008679
UMLS CUI [1,4]
C1514873
UMLS CUI [1,5]
C0087111
Subject with other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of cutaneous microbiome. Common transient conditions, such as acne, are permissible.
Beschreibung

Subject with other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of cutaneous microbiome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0037274
UMLS CUI [1,4]
C0521102
UMLS CUI [1,5]
C0220825
UMLS CUI [1,6]
C0221912
UMLS CUI [1,7]
C1956109
Subjects who work or reside in healthcare facilities or in non-hospital settings that provide healthcare such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals, in order to minimize potential ascertainment bias. Certain pathogens such as *Staphylococcus aureus* and multi-drug resistant organisms are disproportionately associated with delivery of healthcare.
Beschreibung

Subjects who are at high risk of contact with certain pathogens such as *Staphylococcus aureus* and multi-drug resistant organisms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0043227
UMLS CUI [1,4]
C0018704
UMLS CUI [2,1]
C0009932
UMLS CUI [2,2]
C0680251
UMLS CUI [2,3]
C0237096
UMLS CUI [2,4]
C0018704
UMLS CUI [3,1]
C0009932
UMLS CUI [3,2]
C0680251
UMLS CUI [3,3]
C0043227
UMLS CUI [3,4]
C0029921
UMLS CUI [3,5]
C0018704
UMLS CUI [4,1]
C0009932
UMLS CUI [4,2]
C0680251
UMLS CUI [4,3]
C0332183
UMLS CUI [4,4]
C0332158
UMLS CUI [4,5]
C0022877
UMLS CUI [4,6]
C0003062
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Ähnliche Modelle

Eligibility Criteria

6 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
Inclusion Criteria for AD/HIES/WAS patients (unless specified otherwise
Item
*Inclusion Criteria for AD/HIES/WAS patients (unless specified otherwise):*
boolean
Males or females 3 - 40 years of age
Item
Males or females 3 - 40 years of age. Minimum age of 3 enriches for patients that have active AD and are statistically less likely to resolve during this longitudinal study. Maximum age of 40 is to reduce chance of recruiting patients with age-related changes in skin.
boolean
C1512693 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party
Item
AD patients: Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party's Diagnostic Criteria for Atopic Dermatitis. (Reference: Williams HC, Burney PG, Pembroke AC, et al: The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. III. Independent hospital validation. Br J Dermatol 131:406-16, 1994). Included in attachments.
boolean
C1512693 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011615 (UMLS CUI [1,3])
C0041700 (UMLS CUI [1,4])
C0043227 (UMLS CUI [1,5])
C1518904 (UMLS CUI [1,6])
C0679228 (UMLS CUI [1,7])
HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous dermatitis.
Item
HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous dermatitis.
boolean
C1512693 (UMLS CUI [1,1])
C3279428 (UMLS CUI [1,2])
C0043194 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
C0026882 (UMLS CUI [1,5])
C0011603 (UMLS CUI [1,6])
C1512693 (UMLS CUI [2,1])
C3279428 (UMLS CUI [2,2])
C0043194 (UMLS CUI [2,3])
C0011900 (UMLS CUI [2,4])
C0026882 (UMLS CUI [2,5])
C1298908 (UMLS CUI [2,6])
C0011603 (UMLS CUI [2,7])
AD patients: SCORAD more then 25
Item
AD patients: SCORAD (SCORing Atopic Dermatitis) score of ≥ 25 indicating AD severity of moderate to severe. Included in appendix. (Reference: Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31.) Included in attachments.
boolean
C1512693 (UMLS CUI [1,1])
C0011615 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C0871208 (UMLS CUI [1,5])
C0205081 (UMLS CUI [1,6])
C0205082 (UMLS CUI [1,7])
AD patients: At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.
Item
AD patients: At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.
boolean
C1512693 (UMLS CUI [1,1])
C0011615 (UMLS CUI [1,2])
C0449642 (UMLS CUI [1,3])
C0230436 (UMLS CUI [1,4])
C2986546 (UMLS CUI [1,5])
C1301880 (UMLS CUI [1,6])
C1512693 (UMLS CUI [2,1])
C0011615 (UMLS CUI [2,2])
C0449642 (UMLS CUI [2,3])
C0446523 (UMLS CUI [2,4])
C2986546 (UMLS CUI [2,5])
C1301880 (UMLS CUI [2,6])
Must have a primary care professional who will continue care/evaluation in tandem with the protocol to whom information can be communicated.
Item
6. Must have a primary care professional who will continue care/evaluation in tandem with the protocol to whom information can be communicated.
boolean
C1512693 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0033131 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C0017313 (UMLS CUI [1,5])
C2348563 (UMLS CUI [1,6])
C1512693 (UMLS CUI [2,1])
C0033131 (UMLS CUI [2,2])
C0009452 (UMLS CUI [2,3])
C1955348 (UMLS CUI [2,4])
C1508263 (UMLS CUI [2,5])
Exclusion Criteria for AD/HIES/WAS patients
Item
*Exclusion Criteria for AD/HIES/WAS patients:*
boolean
Subjects with unstable or uncontrolled medical conditions
Item
Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
boolean
C0680251 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0035647 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C0019993 (UMLS CUI [1,6])
C0680251 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C1444637 (UMLS CUI [2,3])
C0439231 (UMLS CUI [2,4])
Subjects receiving or planning to receivetreatment; 7 days or 5 half-lives of initiating this protocol.
Item
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
boolean
C0680251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0031765 (UMLS CUI [1,4])
C0003250 (UMLS CUI [1,5])
C0021079 (UMLS CUI [1,6])
C1442452 (UMLS CUI [1,7])
C0808070 (UMLS CUI [1,8])
C0680251 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0031765 (UMLS CUI [2,5])
C0003250 (UMLS CUI [2,6])
C0021079 (UMLS CUI [2,7])
C1442452 (UMLS CUI [2,8])
C0808070 (UMLS CUI [2,9])
AD patients: Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for more than 7 days to small areas of skin intended for sampling.
Item
AD patients: Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for 8805; 7 days to small areas of skin intended for sampling. (Topical therapies for AD may be continued to non-adjacent, non-target sites.)
boolean
C0680251 (UMLS CUI [1,1])
C0011615 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
C3540704 (UMLS CUI [1,6])
C1442452 (UMLS CUI [1,7])
C0332152 (UMLS CUI [1,8])
C1302413 (UMLS CUI [1,9])
C0680251 (UMLS CUI [2,1])
C0011615 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,5])
C2825233 (UMLS CUI [2,6])
C1442452 (UMLS CUI [2,7])
C0332152 (UMLS CUI [2,8])
C1302413 (UMLS CUI [2,9])
C0680251 (UMLS CUI [3,1])
C0011615 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C1512900 (UMLS CUI [3,4])
C0087111 (UMLS CUI [3,5])
C1522168 (UMLS CUI [3,6])
C0038317 (UMLS CUI [3,7])
C1442452 (UMLS CUI [3,8])
C0332152 (UMLS CUI [3,9])
C1302413 (UMLS CUI [3,10])
C0680251 (UMLS CUI [4,1])
C0011615 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C1512900 (UMLS CUI [4,4])
C0087111 (UMLS CUI [4,5])
C1562036 (UMLS CUI [4,6])
C1442452 (UMLS CUI [4,7])
C0332152 (UMLS CUI [4,8])
C1302413 (UMLS CUI [4,9])
AD patients with underlying immunodeficiency, either as primary disease or secondary to treatment
Item
AD patients: Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
boolean
C0680251 (UMLS CUI [1,1])
C0011615 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
C0680251 (UMLS CUI [2,1])
C0011615 (UMLS CUI [2,2])
C0439669 (UMLS CUI [2,3])
C0021051 (UMLS CUI [2,4])
WAS/HIES patients: unable to remain off topical steroids and emollients (skin sampling sites only) for at least 24 hours prior to skin sampling.
Item
WAS/HIES patients: unable to remain off topical steroids and emollients (skin sampling sites only) for at least 24 hours prior to skin sampling. HIES/WAS patients will not be taken off their systemic (oral) antibiotics or systemic (oral) steroids. (Topical therapies may be continued to non-adjacent, non-target sites.)
boolean
C0680251 (UMLS CUI [1,1])
C0043194 (UMLS CUI [1,2])
C3887645 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C1518544 (UMLS CUI [1,5])
C1706203 (UMLS CUI [1,6])
C0013983 (UMLS CUI [1,7])
C1123023 (UMLS CUI [1,8])
C0870078 (UMLS CUI [1,9])
C2825164 (UMLS CUI [1,10])
C1524031 (UMLS CUI [1,11])
C1442770 (UMLS CUI [1,12])
Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.
Item
Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.
boolean
C0680251 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0680251 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0680251 (UMLS CUI [3,1])
C2827774 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C0006826 (UMLS CUI [3,4])
C0680251 (UMLS CUI [4,1])
C0279134 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
Subject with a chronic disease requiring treatment
Item
Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
boolean
C0680251 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Inclusion Criteria for Healthy Volunteers and Age Matched Controls
Item
*Inclusion Criteria for Healthy Volunteers and Age Matched Controls:*
boolean
Males or females 3 - 40 years of age.
Item
Males or females 3 - 40 years of age.
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
Interval visits and age of controls must match enrolled AD patients.
Item
Interval visits and age of controls must match enrolled AD patients.
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C0439089 (UMLS CUI [1,6])
C0030705 (UMLS CUI [1,7])
C0011615 (UMLS CUI [1,8])
Exclusion Criteria for Healthy Volunteers and Age Matched Controls
Item
*Exclusion Criteria for Healthy Volunteers and Age Matched Controls:*
boolean
Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month
Item
Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
boolean
C0009932 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0035647 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0019993 (UMLS CUI [1,7])
C0009932 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0019993 (UMLS CUI [2,5])
C1444637 (UMLS CUI [2,6])
C0205447 (UMLS CUI [2,7])
C0439231 (UMLS CUI [2,8])
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
Item
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants for more than 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
C0680251 (UMLS CUI [3,1])
C0009932 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0031765 (UMLS CUI [3,4])
C0041625 (UMLS CUI [3,5])
C0680251 (UMLS CUI [4,1])
C0009932 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
C0031765 (UMLS CUI [4,5])
C0041625 (UMLS CUI [4,6])
C0680251 (UMLS CUI [5,1])
C0009932 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0021079 (UMLS CUI [5,4])
C0680251 (UMLS CUI [6,1])
C0009932 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
C0087111 (UMLS CUI [6,4])
C0021079 (UMLS CUI [6,5])
C0680251 (UMLS CUI [7,1])
C0009932 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0003250 (UMLS CUI [7,4])
C0680251 (UMLS CUI [8,1])
C0009932 (UMLS CUI [8,2])
C1301732 (UMLS CUI [8,3])
C0087111 (UMLS CUI [8,4])
C0003250 (UMLS CUI [8,5])
Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.
Item
Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
C3540704 (UMLS CUI [1,6])
C1442452 (UMLS CUI [1,7])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,5])
C0442027 (UMLS CUI [2,6])
C2825233 (UMLS CUI [2,7])
C1442452 (UMLS CUI [2,8])
Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
Item
Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
C0439669 (UMLS CUI [2,3])
C0021051 (UMLS CUI [2,4])
Subjects who are currently or have previously received treatment with chemotherapy or radiation.
Item
Subjects who are currently or have previously received treatment with chemotherapy or radiation.
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
C0680251 (UMLS CUI [3,1])
C0009932 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0680251 (UMLS CUI [4,1])
C0009932 (UMLS CUI [4,2])
C1514457 (UMLS CUI [4,3])
Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
Item
Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
boolean
C0009932 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
Subject with other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of cutaneous microbiome
Item
Subject with other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of cutaneous microbiome. Common transient conditions, such as acne, are permissible.
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,4])
C0220825 (UMLS CUI [1,5])
C0221912 (UMLS CUI [1,6])
C1956109 (UMLS CUI [1,7])
Subjects who are at high risk of contact with certain pathogens such as *Staphylococcus aureus* and multi-drug resistant organisms
Item
Subjects who work or reside in healthcare facilities or in non-hospital settings that provide healthcare such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals, in order to minimize potential ascertainment bias. Certain pathogens such as *Staphylococcus aureus* and multi-drug resistant organisms are disproportionately associated with delivery of healthcare.
boolean
C0009932 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0043227 (UMLS CUI [1,3])
C0018704 (UMLS CUI [1,4])
C0009932 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0237096 (UMLS CUI [2,3])
C0018704 (UMLS CUI [2,4])
C0009932 (UMLS CUI [3,1])
C0680251 (UMLS CUI [3,2])
C0043227 (UMLS CUI [3,3])
C0029921 (UMLS CUI [3,4])
C0018704 (UMLS CUI [3,5])
C0009932 (UMLS CUI [4,1])
C0680251 (UMLS CUI [4,2])
C0332183 (UMLS CUI [4,3])
C0332158 (UMLS CUI [4,4])
C0022877 (UMLS CUI [4,5])
C0003062 (UMLS CUI [4,6])
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