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NCT04319237 · ClinicalTrials.gov registry record
Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes
A clinical trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- 60
- Enrollment target
NCT04319237: Completed study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04319237 is a clinical trial that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319237 has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study Summary
The purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.
Primary Outcome
Memory changes will be assessed with the Repeatable Battery for the Assessment of Status (RBANS) which assesses immediate memory (list learning and story memory), visuospatial/constructional abilities (figure copy and line orientation), language (picture naming and semantic fluency), attention (digit span and coding), and delayed memory (list recall, list recognition, story recall, and figure recall) domains. Both total scores and scaled/percentile group scores are calculated for each test and t
Interventions
- OTHER Handgrip strength test
- BEHAVIORAL Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)
- BEHAVIORAL Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)
- BEHAVIORAL Neuropsychological Assessment - Color Trails
- BEHAVIORAL Neuropsychological Assessment -Stroop Color and Word Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2023-07-31 |
What the finished NCT04319237 record still lists
NCT04319237 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which Handgrip strength test is the first listed.
NCT04319237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04319237 about?
NCT04319237 is a clinical study titled "Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes". The purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.
What is the current status of trial NCT04319237?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2020-03-10. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT04319237?
The interventions under investigation include: Handgrip strength test (OTHER), Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR) (BEHAVIORAL), Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS) (BEHAVIORAL), Neuropsychological Assessment - Color Trails (BEHAVIORAL), Neuropsychological Assessment -Stroop Color and Word Test (BEHAVIORAL).
Who is sponsoring clinical trial NCT04319237?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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