Recruiting

SALSA

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT06414278

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06414278

Start date

Feb 8, 2024

Status verified date

Jan, 2026

Completion date

Feb 21, 2028

Anticipated

Primary completion date

Jul 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

38 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Veronika Bachanova

612-625-5469bach0173@umn.edu

Principal Investigator:

Veronika Bachanova

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-01-13.