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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have a hematologic malignancy</li>
<li>Are undergoing treatment with CAR-T or BiTE therapy</li>
<li>Own a smart phone that is compatible with the VitalTraq app and can connect to wi-fi</li>
<li>Can read and understand English</li></ul>
For more information about who can join this study, please contact one of the study team members below:
Chenyu Lin: <a href= "mailto: chenyu.lin@duke.edu">chenyu.lin@duke.edu</a> or 919-684-8964
Jennifer Tichon: <a href= "mailto: jennifer.tichon@duke.edu">jennifer.tichon@duke.edu</a> or 919-668-2556
<li>Have a hematologic malignancy</li>
<li>Are undergoing treatment with CAR-T or BiTE therapy</li>
<li>Own a smart phone that is compatible with the VitalTraq app and can connect to wi-fi</li>
<li>Can read and understand English</li></ul>
For more information about who can join this study, please contact one of the study team members below:
Chenyu Lin: <a href= "mailto: chenyu.lin@duke.edu">chenyu.lin@duke.edu</a> or 919-684-8964
Jennifer Tichon: <a href= "mailto: jennifer.tichon@duke.edu">jennifer.tichon@duke.edu</a> or 919-668-2556
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join the study, you will:<ul>
<li>Have information about your medical history and physical characteristics collected</li>
<li>Wear a TempTraq patch (a device that continuously monitors body temperature) on your skin under your arm for 15 days</li>
<li>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</li>
<li>Take your temperature with a digital thermometer 4-5 times per day for 15 days</li>
<li>Have your blood drawn for research</li>
<li>Complete a post-intervention survey</li></ul>
<li>Have information about your medical history and physical characteristics collected</li>
<li>Wear a TempTraq patch (a device that continuously monitors body temperature) on your skin under your arm for 15 days</li>
<li>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</li>
<li>Take your temperature with a digital thermometer 4-5 times per day for 15 days</li>
<li>Have your blood drawn for research</li>
<li>Complete a post-intervention survey</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Study Website
Principal Investigator
Chenyu
Lin
Protocol Number
PRO00115012
NCT ID
NCT06415656
Phase
N/A
Enrollment Status
Open to Enrollment