Registry for asthma characterization and recruitment
Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)
This study is creating a database of information about childhood asthma in urban areas by enrolling around 1,500 participants of all ages to help with future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 7 sites (Aurora, Colorado and 6 other locations) |
| Trial ID | NCT05272241 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, non-interventional registry aimed at creating and maintaining a database of participants for current and future studies on childhood asthma in urban settings. Approximately 1,500 participants of all ages will be enrolled from selected metropolitan areas. The registry will gather data during a core visit and may include optional follow-up visits, assessing various asthma and allergy characteristics. Healthy controls may also be invited to participate for validation and training purposes, ensuring a comprehensive approach to participant recruitment.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older or minors accompanied by a legal guardian, residing in specific metropolitan areas.
Not a fit: Patients who do not speak English or Spanish or lack regular access to a phone may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of asthma in urban settings and improve recruitment for future studies, ultimately leading to better asthma management strategies.
How similar studies have performed: Other studies utilizing similar registry approaches have shown promise in enhancing participant recruitment and data collection, indicating a potentially successful methodology.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 6 other locations
- Children's Hospital Colorado: Allergy Program — Aurora, Colorado, United States (Recruiting)
- Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site — Washington D.C., District of Columbia, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology — Chicago, Illinois, United States (Recruiting)
- Boston Children's Hospital: Department of Immunology — Boston, Massachusetts, United States (Not_yet_recruiting)
- Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute — New York, New York, United States (Recruiting)
- Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine — New York, New York, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.