Characterization of Adult Subjects for Asthmatic Research Studies (CASA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01508078|
Recruitment Status : Recruiting
First Posted : January 11, 2012
Last Update Posted : March 8, 2019
|Condition or disease|
The purpose of this study is to generate a cohort of well-characterized asthmatic subjects as a resource for recruitment of asthmatic subjects and healthy controls in clinical studies and clinical trials in the UCSF Airway Clinical Research Center. The UCSF Airway Clinical Research Center (ACRC) conducts multiple clinical research studies in asthma funded by the NIH, foundations, and industry. We have a broad range of research interests, but we have specific interests in mechanism-oriented clinical studies and specific expertise in biospecimen collection, biobanking, and biospecimen analysis. Our model is to have multiple studies recruiting simultaneously, and this means that we need well-organized recruitment and database systems.
Additionally, we aim to characterize asthmatic subjects in multiple domains, including disease severity, airway inflammation subtypes, and mucus subtypes. Asthma is a heterogeneous disease in its clinical presentation and in its underlying cellular and molecular phenotypes. To explore cellular and molecular phenotypes of asthma, we will analyze induced sputum for cell types and gene expression, with a focus on Th2 inflammation pathways and innate and adaptive immune cells that drive Th2 inflammation. Detailed cellular analysis of sputum is possible but requires that multiple sputum samples be collected for processing in multiple different ways, including by cytocentrifugation, FACS analysis, and by formalin fixation and paraffin embedding of sputum cell pellets. We are also studying mucus phenotypes of asthma using methods of rheology, which needs to be done on fresh sputum.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Characterization of Adult Subjects for Asthmatic Research Studies|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Otherwise healthy asthmatic subjects
Healthy individuals without evidence of pulmonary disease.
- Airway inflammation [ Time Frame: Cross-sectional ]We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508078
|Contact: Ariana Baum||415-514-1539||Ariana.Baum@ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Ariana Baum 415-514-1539 email@example.com|
|Principal Investigator: John V Fahy, MD|
|Principal Investigator:||John Fahy, MD||University of California, San Francisco|