Clinical trial · Interventional
Assessing DCog Short for Neurotoxicity in CAR-T
Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study
NCT07403812CI-TRIAL-00103060not yet recruitingN/AClinicalTrials.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)
The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Immune Effector Cell Associated Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Neurotoxicity Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCog Short | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T Cell Therapy Patients
- description
- 40 enrolled participants will complete: * Baseline visit * Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30 * 90 Day follow up visit
- interventionNames
- Behavioral: DCog Short
Primary outcomes (5)
- measure
- Sensitivity of DCog Short for Early Detection of Neurotoxicity
- timeFrame
- Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
- description
- Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to detect neurotoxicity on or before the onset of clinically confirmed ICANS. Sensitivity is defined as the proportion of patients with clinically confirmed ICANS for whom DCog Short indicates neurotoxicity on or before ICANS onset. DCog Short will be considered effective if sensitivity is ≥75% and non-promising if sensitivity is \<50%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity. * Visual acuity of 20/100 or better. Exclusion Criteria: * patients \< 18 years old * pregnant women * prisoners * adults unable to consent, * participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad
References
Publications (0)
Data not yet available
No reference posted for this study.