Evaluation of Early Identification of Cognitive Side Effe... | NCT06414278

Studies
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

NCT06414278

Sponsor

Masonic Cancer Center, University of Minnesota

Status

Recruiting

Last Update Posted

Jan 13, 2026Actual

Enrollment

38Estimated

Phase

Not provided

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2023-09048	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2022LS089	Other Identifier	University of Minnesota/Masonic Cancer Center
P30CA077598	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2024Actual

Primary Completion Date

Jul 21, 2027Estimated

Completion Date

Feb 21, 2028Estimated

First Submitted Date

May 8, 2024

First Submission Date that Met QC Criteria

May 13, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 13, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients planning to undergo CAR-T therapy for primary malignancy recruited through the University of Minnesota.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronika Bachanova	Masonic Cancer Center, University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota/Masonic Cancer Center	Recruiting	Minneapolis	Minnesota	55455	United States