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NCT04355780 · ClinicalTrials.gov registry record
Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 10
- Enrollment target
NCT04355780: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT04355780 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04355780 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure. Primary Objective To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients. Secondary Objectives * To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases. * To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure. * To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases. Exploratory Objectives To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site. To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.
Primary Outcome
Feasibility is a qualitative binary outcome (Yes and No), based on the success of recovery of more than 100,000 live cells from a tracheal aspirate and blood sample from five of the first ten allo HCT patients enrolled on the study protocol.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-01-08 |
| Est. Completion | 2023-08-30 |
What the finished NCT04355780 record still lists
NCT04355780 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04355780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04355780 about?
NCT04355780 is a clinical study titled "Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients". This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure. Primary Objective To evaluate the feasibility of performing single cell gene expr...
What is the current status of trial NCT04355780?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2021-01-08. Estimated completion is 2023-08-30.
Who is sponsoring clinical trial NCT04355780?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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