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This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.
Protocol CAUSE-02 RACR3 is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies. Approximately 1,500 participants - of all ages, living in selected Office of Management and Budget (OMB) defined Metropolitan Statistical Areas (MSAs) will be enrolled in the registry.
The registry database will be generated with data gathered at a single core visit, followed by optional additional visits. The registry will include assessments of various asthma and allergy characteristics to achieve a more flexible, efficient, selective, and inclusive approach to participant recruitment while still following national guidelines to foster participant safety. CAUSE investigators may invite children or adults without asthma or atopic diseases to participate in the registry as "healthy" controls; for validation of laboratory tests, study monitoring equipment, and/or procedures; or for site procedure training of study personnel for certification and quality assurance.
Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with asthma and allergy characteristics | Characteristics of the participants enrolled in the registry will be assessed on a periodic basis (descriptive summary of diagnosis and parameters associated with the former). | 7 years |
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Inclusion Criteria:
Participant is either:
Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)
Exclusion Criteria:
Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy.
Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.
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The population enrolled in this registry will be participants living within the Metropolitan Statistical Area (MSA) assigned by the Office of Management and Budget (OMB) for a given clinical site.
The Protocol Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) eligibility criteria are broad to anticipate diverse recruitment needs for current and future CAUSE protocols.
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| Name | Affiliation | Role |
|---|---|---|
| Christine A. Sorkness, RPh, PharmD | University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology | Study Chair |
| Daniel J. Jackson, MD | University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado: Allergy Program | Recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Whole Blood Serum
| Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology | Recruiting | Chicago | Illinois | 60611 | United States |
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| Boston Children's Hospital: Department of Immunology | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute | Recruiting | New York | New York | 10029 | United States |
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| Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine | Not yet recruiting | New York | New York | 10032 | United States |
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| Cincinnati Children's Hospital Medical Center: Asthma Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |