Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Suspended

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06414278
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study Start: 2024-02-08
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-07-21
• Study Completion: 2028-02-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization	18 months	Descriptive statistics will be used to summarize the feasibility of SALSA in CAR-T patients. The overall completion rate of will be calculated for each patient, as well as the pattern of completions.

Trial Locations

Locations (1)

University of Minnesota/Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States