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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04397861
The ClinicalTrials.gov registry entry for NCT04397861 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (37% lower). The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04397861 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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