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NCT04614987 · ClinicalTrials.gov registry record
Serum Neurofilament Light (NfL) as a Marker for Brain Injury in Individuals Undergoing Chimeric Antigen Receptor-modified T Therapy
A clinical trial, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- 17
- Enrollment target
NCT04614987: Clinical Trial study, sponsored by Washington University School of Medicine.
NCT04614987 is a clinical trial that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614987 was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- 17 participants
- Enrollment target
Study Summary
The investigators propose that immune effector cell-associated neurotoxicity syndrome (ICANS) is predicated upon the early loss of blood brain barrier (BBB) integrity with subsequent monocyte infiltration leading to cross-activation of native glial cells. Glial overstimulation leads to neuroinflammation, synaptic dysfunction, and ultimately neuronal injury.
Primary Outcome
* This includes serum (GFAP and NfL) and CSF biomarkers (NfL, VILIP-1, YKL-40, TREM2, and Neurogranin) measured using a single molecule array in pg/ml * Descriptive statistics will be used to summarize a given biomarker level at different time points.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2023-09-13 |
Why NCT04614987 stopped before completion
NCT04614987 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04614987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04614987 about?
NCT04614987 is a clinical study titled "Serum Neurofilament Light (NfL) as a Marker for Brain Injury in Individuals Undergoing Chimeric Antigen Receptor-modified T Therapy". The investigators propose that immune effector cell-associated neurotoxicity syndrome (ICANS) is predicated upon the early loss of blood brain barrier (BBB) integrity with subsequent monocyte infiltration leading to cross-activation of native glial cells. Glial overstimulation leads to neuroinflamma...
What is the current status of trial NCT04614987?
This trial is currently terminated. The enrollment target is 17 participants. The study started on 2021-02-25. Estimated completion is 2023-09-13.
Who is sponsoring clinical trial NCT04614987?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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