Clinical trial · Observational
Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was activated at the onset of the COVID pandemic. At that time voluntary, non-therapeutic research was placed on hold. Now the technology has evolved and have elected to forego this protocol.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable Sensors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants
- description
- 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.
- interventionNames
- Other: Wearable Sensors
Primary outcomes (2)
- measure
- Feasibility phase
- timeFrame
- 5 weeks
- description
- 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.
- measure
- Completion phase
- timeFrame
- 5 weeks
- description
- This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available