Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

University of Minnesota (UMN)

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06414278

NCI-2023-09048 (Registry Identifier)

P30CA077598 (U.S. NIH Grant/Contract)

2022LS089 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Observational

Description:

Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.

Treatment:

Other: Non-Interventional Study