Registry of Asthma Characterization and Recruitment 3 (RACR3)

Recruiting

• Conditions: Asthma

• Registration Number: NCT05272241
• Lead 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.

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 Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Study Start: 2022-04-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with asthma and allergy characteristics	7 years	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).

Trial Locations

Locations (7)

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology; 🇺🇸 Chicago, Illinois, United States

Boston Children's Hospital: Department of Immunology; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Colorado: Allergy Program; 🇺🇸 Aurora, Colorado, United States

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site; 🇺🇸 Washington, District of Columbia, United States

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute; 🇺🇸 New York, New York, United States

Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital Medical Center: Asthma Center; 🇺🇸 Cincinnati, Ohio, United States