What this study is
Simplified from ClinicalTrials.govTesting a wearable core body temperature sensor patch to see whether it can spot cytokine release syndrome (a dangerous immune reaction that can follow CAR T-cell therapy) earlier than standard oral temperature checks, in adults 18 and older getting CAR T-cell therapy as outpatients.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- TempShield Continuous Temperature Monitoring
Intervention · OTHER
Patient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee.
- Standard of Care
Intervention · OTHER
Standard of care oral temperature monitoring
Study details
- Official title
- 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
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Myeloma
- Enrolling
- 105 people
- Starts
- 2026-12
- Est. completion
- 2029-01-02
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Planned prophylactic tocilizumab for mitigation of CRS as documented in the clinical trials pathway submission
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openAtrium Health Levine Cancer
Charlotte, North Carolina, United States
- Courtney Schepel · Contact980-442-2327Courtney.Schepel@advocatehealth.org
- Cindy Varga, MD · Principal investigator
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
- John McKay, DO · ContactJohn.Mckay@wfusm.edu
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00158734
Principal investigator
Cindy Varga, MD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.