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NCT Number: NCT06414278

Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

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.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Veronika Bachanova

CONTACT

[email protected]

612-625-5469

Veronika Bachanova

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Early Identification of Cognitive Side-Effects of Immunotherapy

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 16, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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