Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Area under the receiver operating characteristic (ROC) curve of continuous score from the pre-specified classifier in predicting relapse after complete response to cytarabine- based induction chemotherapy
研究概览
简要总结
RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a patient's risk of relapse and plan better treatment for acute myeloid leukemia.
PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well it works in predicting risk of relapse in bone marrow cell samples from younger patients with acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- To validate the accuracy of the My Profile Pediatric Assay to predict risk of relapse in pediatric patients with non-M3 acute myeloid leukemia (AML) who responded to cytarabine-based induction chemotherapy.
Secondary
- To validate the continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, MRD, and bone marrow (BM) donor availability.
- To validate the accuracy of the prespecified low versus high relapse indicator variable (I_L/H) as a predictor of relapse after induction therapy.
- To validate the accuracy of the prespecified I_L/H as a predictor of relapse after induction therapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: MRD, age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, and BM donor availability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Area under the receiver operating characteristic (ROC) curve of continuous score from the pre-specified classifier in predicting relapse after complete response to cytarabine- based induction chemotherapy
时间窗: Up to 3 years
A logistic regression model and area under the ROC curve for the model will be tested for significance against a null value of 0.5.
次要结局
- Continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy(Up to 3 years)