Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
Key facts
- Where
- Charlotte and Winston-Salem, United StatesSee the 2 sites
Where in United States
- Atrium Health Levine CancerCharlotte, United StatesNo longer taking part
- Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT07911540
- Record updated
- 5 November 2026
- Original description
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.Read full original descriptionShow less
A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
Inclusion: Patients:; Ability to understand and willingness to sign an IRB-approved informed consent; Age ≥ 18 years at the time of consent; Scheduled to undergo CAR-T therapy in the outpatient setting at AHWFBCCC; Ability to read and understand the English and/or Spanish language; As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study; Access to a mobile device for the duration of the trial; Provider/Staff:; Provider/staff participants must meet all of the following inclusion criteria to participate in the study:; Verbally agree to participate; Hospital at Home outpatient provider/advanced practice provider/nurse of at least one patient participant enrolled on Arm A who completed 14 days of temperature monitoring.
Exclusion: History of silicone allergy; History of Medical Adhesive-Related Skin Injury (MARSI); Known skin condition that might preclude safe application of the patch, in the opinion of the enrolling investigator; Provider/Staff:; None; Patients:; Planned prophylactic tocilizumab for mitigation of CRS as documented in the clinical trials pathway submission.