NCT06414278

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Feb 2024Feb 2028

Study Start

First participant enrolled

February 8, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

May 8, 2024

Last Update Submit

January 12, 2026

Conditions

Malignant Solid NeoplasmHematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Observational

Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \* ≥ 18 years of age at initiation of therapy
  • Planning to undergo inpatient CAR-T therapy for primary malignancy
  • Fluent in English (written or spoken)

You may not qualify if:

  • \* 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

  • Veronika Bachanova

    University of Minnesota Masonic Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 16, 2024

Study Start

February 8, 2024

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

February 21, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

US(1)