Assessing DCog Short for Neurotoxicity in CAR-T
{ "Assessing DCog Short for Neurotoxicity in CAR-T Therapy", "This study is testing a new iPad-based tool called DCog Short. This tool is designed to help doctors find out if patients receiving CAR-T cell therapy are experiencing neurotoxicity (problems with the brain or nervous system). Researchers want to see how well DCog Short can detect these issues early. You might be able to join if you are 18 or older, are receiving CAR-T cell therapy, and have good vision. The study aims to enroll about 40 people. The current status of this study is unclear, so it's not known if they are actively looking for participants right now.", "design": "This is an interventional study with an estimated enrollment of 40 participants. It is a pilot study, meaning it's the first time researchers are examining this tool.", "commitments": "You would complete questionnaires and cognitive assessments using an iPad. After leaving the hospital, you will be given an iPad to use, which you will return at your 90-day follow-up visit.", "compensation": "Not stated in the trial record.", "follow_up": "Your cognitive function will be measured until 30 days after your CAR T-cell infusion, and you will return the iPad at a 90-day follow-up visit.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessing DCog Short for Neurotoxicity in CAR-T
At a glance
Conditions
NCT07403812
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jon Arnason, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Sensitivity of DCog Short for Early Detection of NeurotoxicityUntil 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
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%.
- Specificity of DCog Short for Early Detection of NeurotoxicityUntil 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
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 correctly identify patients who do not develop neurotoxicity. Specificity is defined as the proportion of patients who do not develop clinically confirmed ICANS and are not indicated by DCog Short. DCog Short will be considered effective if specificity is ≥75% and non-promising if specificity is \<50%.
- Positive Predictive Value (PPV) of DCog Short for Early Detection of NeurotoxicityUntil 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
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 correctly identify patients who do not develop neurotoxicity. Positive predictive value is defined as the proportion of patients indicated by DCog Short who subsequently develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.
- Negative Predictive Value (NPV) of DCog Short for Early Detection of NeurotoxicityUntil 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
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 correctly identify patients who do not develop neurotoxicity. Negative predictive value is defined as the proportion of patients not indicated by DCog Short who do not develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.
- Raw Accuracy of DCog Short for Early Detection of NeurotoxicityUntil 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
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 correctly identify patients who do not develop neurotoxicity. Raw accuracy is defined as the proportion of patients correctly classified by DCog Short, including both patients who develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and those who do not, based on standard clinical assessment.