Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04397809
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-05-18
Brief Title:
Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
Sponsor:
National Jewish Health
Organization:
National Jewish Health
Study Overview
Official Title:
Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cystic fibrosis CF is the most common inherited disease in the western world On a yearly basis 56 of CF patients or nearly 17000 individuals in the US suffer from acute pulmonary exacerbations APE The purpose of this study is to test a candidate assay for its ability to diagnose APE the most important disease event in CF While previous studies have been able to identify biomarkers of CF prognosis and risk stratification three markers have demonstrated characteristics ideal for APE diagnosis CD64 TLR2 and GILT CD64 is a cellular receptor expressed on numerous cells of the immune system whose role is to bind antibodies which are attached to infected cells or pathogens TLR2 plays a major role in early host-microbial interactions GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response This study looks to identify the differences in the expression of neutrophil CD64 and CD4 T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition The study also looks to compare sensitivity and specificity of the assays above to standard measures such as health related quality of life scores CFQ-R loss of lung function white blood cell counts and CRP for diagnosing acute exacerbations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None