Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of DCog Short for Early Detection of Neurotoxicity
研究概览
简要总结
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.
详细描述
The goal of this pilot 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. This is the first time investigators are examining this tool.
The U.S. Food and Drug Administration (FDA) has not approved DCOG Short as a mobile application tool to evaluate neurotoxicity for hematologic malignancies.
The research study procedures include screening for eligibility, questionnaires, and cognitive assessments.
It is expected that about 40 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.
- •Visual acuity of 20/100 or better.
排除标准
- •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
研究组 & 干预措施
CAR-T Cell Therapy Patients
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
干预措施: DCog Short (Behavioral)
结局指标
主要结局
Sensitivity of DCog Short for Early Detection of Neurotoxicity
时间窗: Until 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 Neurotoxicity
时间窗: Until 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 Neurotoxicity
时间窗: Until 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 Neurotoxicity
时间窗: Until 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 Neurotoxicity
时间窗: Until 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.
次要结局
- Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline(Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.)
- Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types(Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.)
研究者
Jon Arnason
Principal Investigator
Beth Israel Deaconess Medical Center