Clinical trial · Observational
Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
Early Identification of Cognitive Side-Effects of Immunotherapy
NCT06414278CI-TRIAL-00100753recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization
- timeFrame
- 18 months
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.