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NCT05272241 | RECRUITING | Asthma

Registry of Asthma Characterization and Recruitment 3 (RACR3)
Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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.

Condition or disease

Asthma

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1500 participants
Official Title : Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)
Actual Study Start Date : 2022-04-15
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Participant is either
    • 1. At least 18 years old, willing and able to provide informed consent at the time of enrollment
    • 2. Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
    • 2. Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)
    Exclusion Criteria
    • 1. Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
    • 2. Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
    • 3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study
    • 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.
Registry of Asthma Characterization and Recruitment 3 (RACR3)

Location Details

NCT05272241

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, United States, 80045

RECRUITING

United States, District of Columbia

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site

Washington D.C., District of Columbia, United States, 20010

RECRUITING

United States, Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, United States, 60611

NOT YET RECRUITING

United States, Massachusetts

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, United States, 10029

NOT YET RECRUITING

United States, New York

Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

New York, New York, United States, 10032

RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, United States, 45229