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NCT06414278 Clinical Trial

Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Malignant Solid Neoplasm Clinical Trial

Official title:
Early Identification of Cognitive Side-Effects of Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06414278
Other study ID # 2022LS089
Secondary ID NCI-2023-0904820
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2024
Est. completion date February 21, 2028

Study information
Verified date May 2024
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date February 21, 2028
Est. primary completion date July 21, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization 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. 18 months
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