VitalTraq for Detection of CRS (Cytokine Release Syndrome) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to evaluate the accuracy and utility of two remote vital sign monitoring devices, called TempTraq and VitalTraq, when used by blood cancer patients receiving chimeric antigen receptor (CAR) T-cell and bispecific T-cell engager (BiTE) therapies. In the future, these remote vital sign monitoring devices may help with earlier detection and intervention of treatment side effects, including cytokine release syndrome (CRS) and infections.

What is the Condition Being Studied?

Blood Cancers Treated with Chimeric Antigen Receptor T-Cell (CAR-T) Therapy or Bispecific T-Cell Engagers (BiTE)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have a hematologic malignancy
  • Are undergoing treatment with CAR-T or BiTE therapy
  • Own a smart phone that is compatible with the VitalTraq app and can connect to wi-fi
  • Can read and understand English

For more information about who can join this study, please contact one of the study team members below:

Chenyu Lin: chenyu.lin@duke.edu or 919-684-8964

Jennifer Tichon: jennifer.tichon@duke.edu or 919-668-2556

Age Group
Adults

What is Involved?

If you choose to join the study, you will:

  • Have information about your medical history and physical characteristics collected
  • Wear a TempTraq patch (a device that continuously monitors body temperature) on your skin under your arm for 15 days
  • Scan your face in VitalTraq (a mobile application that estimates blood pressure, heart rate, heart rate variability, and respiratory rate) 4-5 times per day for 15 days
  • Take your temperature with a digital thermometer 4-5 times per day for 15 days
  • Have your blood drawn for research
  • Complete a post-intervention survey

Study Details

Full Title
Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome from Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00115012
NCT: NCT06415656
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment