Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Other: Wearable Sensors

• Registration Number: NCT04322084
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

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.

Detailed Description

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.

This study aims to determine whether continuous analysis of those biosignals in children treated for ALL can predict early onset of sepsis. To collect those biosignals, we combine two wearable sensors, namely TempTraq, an adhesive temperature sensor, and Empatica E4, a wearable physiological monitoring device.

Data will be collected during two selected high-risk 5-day periods of induction therapy for acute lymphoblastic leukemia. Statistical models will be applied and a series of validation methodologies will be developed to arrive at an optimal predictive model for subsequent external validation .

This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide sufficient data for the development of predictive models and the estimation of the sensitivity and specificity of these models .

Feasibility Phase

The feasibility phase of the study will comprise the first 10 study participants, including at least 3 in each age group (5 to \<10 years, and \>/= 10 years). 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

Completion Phase

The Completion Phase will comprise approximately 55 participants. Enrollment will continue until:

1. A total of 15 participants have experienced a fever or sepsis event for the prediction model, and

2. At least 15 participants have completed the study without experiencing a fever or sepsis event.

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Study Start: 2024-09
• Primary Completion: 2024-10
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Wearable Sensors	Participants will be enrolled during induction therapy for ALL, before the first high-risk period of treatment, and will contribute data for two 5-day periods of continuous monitoring.

Primary Outcome Measures

Name	Time	Method
Completion phase	5 weeks	This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
Feasibility phase	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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States