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NCT04397809 · ClinicalTrials.gov registry record
Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
A clinical trial of Cystic Fibrosis, sponsored by National Jewish Health.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT04397809: Completed study of Cystic Fibrosis, sponsored by National Jewish Health.
NCT04397809 is a study of Cystic Fibrosis that has completed, run by National Jewish Health. The registered enrollment target is 150 participants, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04397809, a study of Cystic Fibrosis, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Cystic fibrosis (CF) is the most common inherited disease in the western world. On a yearly basis, 56% of CF patients, or nearly 17,000 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.
Primary Outcome
The primary outcome measure is the difference in expression of neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Conditions Studied
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2014-09-10 |
| Est. Completion | 2021-08-31 |
What the finished NCT04397809 record still lists
NCT04397809 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04397809 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04397809 about?
NCT04397809 is a clinical study titled "Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis". Cystic fibrosis (CF) is the most common inherited disease in the western world. On a yearly basis, 56% of CF patients, or nearly 17,000 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 ...
What is the current status of trial NCT04397809?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2014-09-10. Estimated completion is 2021-08-31.
What conditions does trial NCT04397809 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
Who is sponsoring clinical trial NCT04397809?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04397809 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04397809's enrollment target sits among peer trials
150 43rd of 169 higher than 125 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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