Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414278
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Early Identification of Cognitive Side-Effects of Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates the use of a tool kit Stress Affect Language and Speech Analysis SALSA for early identification of cognitive side effects of immunotherapy compared to the standard of care assessment
Detailed Description:
PRIMARY OBJECTIVES
I To investigate the use of a toolkit for automated administration and scoring of cognitive tests Stress Language and Speech Analysis or SALSA in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy CAR-T products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome ICANS
OUTLINE This is an observational study
Patients complete SALSA assessment and ICE assessments on study Patients also have their medical records reviewed on study
I To investigate the use of a toolkit for automated administration and scoring of cognitive tests Stress Language and Speech Analysis or SALSA in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy CAR-T products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome ICANS
OUTLINE This is an observational study
Patients complete SALSA assessment and ICE assessments on study Patients also have their medical records reviewed on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA077598 | NIH | University of MinnesotaMasonic Cancer Center | httpsreporternihgovquickSearchP30CA077598 |
| NCI-2023-09048 | REGISTRY | None | None |
| 2022LS089 | OTHER | None | None |