Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

May 13, 2024 updated by: Masonic Cancer Center, University of Minnesota

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Principal Investigator:
          • Veronika Bachanova
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Veronika Bachanova, University of Minnesota Masonic Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

February 21, 2028

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022LS089 (Other Identifier: University of Minnesota/Masonic Cancer Center)
  • P30CA077598 (U.S. NIH Grant/Contract)
  • NCI-2023-09048 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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