NCT06414278

Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Early Identification of Cognitive Side-Effects of Immunotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 38 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2024-02-08
• Primary completion: 2027-07-21
• Completion: 2028-02-21
• First posted: 2024-05-16
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States