## Protocol Section
### Identification Module
**NCT ID:** NCT06414278

**Brief Title:** Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

**Official Title:** Early Identification of Cognitive Side-Effects of Immunotherapy

#### Organization Study ID Info
**ID:** 2022LS089
#### Organization
**Class:** OTHER
**Full Name:** Masonic Cancer Center, University of Minnesota
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2023-09048
**Type:** REGISTRY
**Domain:** University of Minnesota/Masonic Cancer Center
**ID:** 2022LS089
**Type:** OTHER
**ID:** P30CA077598
**Link:** https://reporter.nih.gov/quickSearch/P30CA077598
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-02-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-07-21

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Masonic Cancer Center, University of Minnesota

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Hematopoietic and Lymphatic System Neoplasm

- Malignant Solid Neoplasm

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 38

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Non-Interventional Study

**Label:** Observational

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Observational

**Description:** Non-interventional study

**Name:** Non-Interventional Study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization

**Time Frame:** 18 months

### 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Minneapolis

**Contacts:**

***Contact 1:***

- **Email:** bach0173@umn.edu

- **Name:** Veronika Bachanova

- **Phone:** 612-625-5469

- **Role:** CONTACT

***Contact 2:***

- **Name:** Veronika Bachanova

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Minnesota/Masonic Cancer Center

**State:** Minnesota

**Status:** RECRUITING

**Zip:** 55455

#### Overall Officials

**Official 1:**

**Affiliation:** University of Minnesota Masonic Cancer Center

**Name:** Veronika Bachanova

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
