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Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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

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

Study details

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

NCT06414278

Masonic Cancer Center, University of Minnesota

28 May 2024

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