- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322084
Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- A total of 15 participants have experienced a fever or sepsis event for the prediction model, and
- At least 15 participants have completed the study without experiencing a fever or sepsis event.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joshua Wolf, MBBS,PhD
- Phone Number: 866-278-5833
- Email: referralinfo@stjude.org
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
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Contact:
- Joshua Wolf, MBBS,PhD
- Phone Number: 866-278-5833
- Email: referralinfo@stjude.org
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Principal Investigator:
- Joshua Wolf, MBBS,PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
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.
|
To develop predictive algorithms that identify early onset of sepsis in children being treated for ALL.
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 data for the design of predictive models.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility phase
Time Frame: 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.
|
5 weeks
|
Completion phase
Time Frame: 5 weeks
|
This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
|
5 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joshua Wolf, MBBS, PhD, St. Jude Children's Research Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMPER-ALL
- NCI-2011-01222 (Registry Identifier: NCI Clinical Trial Registration Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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