NCT06414278Recruiting

Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Masonic Cancer Center, University of Minnesota

Start Date

2/8/2024

Completion Date

2/21/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * \* ≥ 18 years of age at initiation of therapy * Planning to undergo inpatient CAR-T therapy for primary malignancy * Fluent in English (written or spoken) Exclusion Criteria: * \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA * Subjects with diagnosed cognitive impairment prior to CAR-T therapy * Unwilling or unable to sign voluntary written consent

Interventions

OTHER

Non-Interventional Study

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Conditions

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Locations

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota 55455

United States