Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Completion phase
研究概览
简要总结
Acute lymphoblastic leukemia (ALL) is the most common cancer of childhood and long-term survival has risen to above 90%, but 1-4% of treated patients die from infections. Early detection and treatment of infection can improve these outcomes by preventing increased severity and death. This study aims to determine whether continuous analysis of information from wearable devices (Like a watch and sticky patch) that measure temperature, pulse rate, oxygen level, and other similar information can predict infection before it is apparent to the patient or caregiver. About 65 patients will be enrolled and will wear these devices for 10 days; during that time the information will be recorded, but not available. After completion, information collected immediately before infection will be compared to other times to identify features that predict infections.
详细描述
Primary Objectives (Feasibility Phase) To determine the feasibility of non-invasive collection of continuous physiological data in children with acute lymphoblastic leukemia during outpatient treatment.
(Completion Phase) To develop competing sepsis prediction algorithms using continuous physiological data during outpatient treatment in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
Secondary Objectives To estimate the PPV and NPV of competing sepsis prediction algorithms using continuous physiological data for prediction of fever and sepsis in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the frequency of undocumented fever episodes in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the time from detection of fever or sepsis by a wearable device to identification by standard practice in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 5 and 25 years of age at time of study enrollment
- •Undergoing induction therapy for acute lymphoblastic leukemia at St. Jude
- •Expected to remain outpatient during periods of high infection risk
排除标准
- •Documented allergy to components of the device (Empatica E4: elemental silver, polyurethane, or polycarbonate; TempTraq: latex-free adhesive).
- •Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- •Current fever or sepsis at time of enrollment
结局指标
主要结局
Completion phase
时间窗: 5 weeks
This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
Feasibility phase
时间窗: 5 weeks
The aim of this stage is to estimate the proportion of time that continuous monitoring data are available, and these results will determine whether the study progresses to the completion phase.
次要结局
未报告次要终点