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

NCT04322084 | Withdrawn

• 2 other identifiers: CAMPER-ALLNCI-2011-01222
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL

Outcome Measures

Primary Outcomes (2)

• Feasibility phase

  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

  This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.

  5 weeks

Study Arms (1)

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.

Other: Wearable Sensors

Interventions

Wearable Sensors OTHER

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.

Participants

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All Participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Joshua Wolf, MBBS, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: September 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

US (1)