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NOT YET RECRUITING
NCT07911540
NA

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

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-12

Completion Date

2029-01-02

Last Updated

2026-11-02

Healthy Volunteers

No

Conditions

Interventions

OTHER

TempShield Continuous Temperature Monitoring

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.

OTHER

Standard of Care

Standard of care oral temperature monitoring

Locations (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States