Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Early Identification of Cognitive Side-Effects of Immunotherapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06414278

Enrollment

Registered

2024-05-16

Start date

2024-02-08

Completion date

2028-02-21

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026