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NCT04397861 · ClinicalTrials.gov registry record
T Cell Memory Fuels the Innate Response in Chronic CF Lung Disease
A clinical trial of Cystic Fibrosis, sponsored by National Jewish Health.
- Completed
- Registry status
- 112
- Enrollment target
- 1
- Study location
NCT04397861: Completed study of Cystic Fibrosis, sponsored by National Jewish Health.
NCT04397861 is a study of Cystic Fibrosis that has completed, run by National Jewish Health. The registered enrollment target is 112 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04397861, a study of Cystic Fibrosis, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
This study seeks to define the role of CD4+ and CD8+ T cell memory responses in the immunologic failure of patients with cystic fibrosis (CF) to clear infections. In a normal host, the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection, in great part due to the recall and effector functions of memory T cells. In CF, far less is understood regarding the response of T cell memory when hosts reencounter antigens, otherwise known as pulmonary exacerbations. Pulmonary exacerbations are pivotal events that lead to a decline in health status among CF patients, with many never recovering to baseline health. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Following enrollment at the time of antibiotic initiation, blood will be collected at two different time points. The first samples will be collected within 24 hours of starting IV antibiotic therapy. The second blood specimen will be collected at the end of hospitalization, after a minimum of 5 days. At the time of each blood draw, complete blood counts, a sputum sample, and simple spirometry will be measured as part of the standard care of a CF exacerbation. Isolated PBMCs will be stained with antibodies to designate cell surface phenotype. They will then be sorted to identify the T cell population. These cells will be tested on their ability to clear pathogens. The relationship between cellular immune responses and clinical indicators of pulmonary status will be examined by fitting linear mixed models.
Primary Outcome
Prospectively evaluate CD4+ and CD8+ T cell function as measured from the peripheral blood in patients with cystic fibrosis (CF) and its correlation with improvements in pulmonary inflammation and clinical status during treatment of CF pulmonary exacerbations.
Conditions Studied
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2015-05-06 |
| Est. Completion | 2021-11-01 |
What the finished NCT04397861 record still lists
NCT04397861 is an observational study that tracks outcomes without assigning an intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04397861 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04397861 about?
NCT04397861 is a clinical study titled "T Cell Memory Fuels the Innate Response in Chronic CF Lung Disease". This study seeks to define the role of CD4+ and CD8+ T cell memory responses in the immunologic failure of patients with cystic fibrosis (CF) to clear infections. In a normal host, the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection, in ...
What is the current status of trial NCT04397861?
This trial is currently completed. The enrollment target is 112 participants. The study started on 2015-05-06. Estimated completion is 2021-11-01.
What conditions does trial NCT04397861 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
Who is sponsoring clinical trial NCT04397861?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04397861 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
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04397861's enrollment target sits among peer trials
112 55th of 169 higher than 115 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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