Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Primary Purpose
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biostrap arm band
Sponsored by
About this trial
This is an interventional supportive care trial for Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
Participant must be in the process of undergoing cancer cell therapy at Stanford University.
- Adults > 18 years
- Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
- English speaking
- Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection
Exclusion Criteria:
- In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Device physiological monitoring
Microsampling
Biostrap mobile App
Arm Description
Patients will receive wearable sensor devices (Biostrap arm band)
Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.
Data collection from wearable sensor.
Outcomes
Primary Outcome Measures
Monitoring heart rate data
Monitoring temperature data
Secondary Outcome Measures
Microsampling
microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm
Safety of wearable devices
Safety will be measured by skin irritation, rash. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices
Safety of the microsampling device
Microsampling will be measured by process such as minor bruising, bleeding, or infection. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05123001
Brief Title
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Official Title
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity.
Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T):
To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
To generate comprehensive multiomic profile analysis following CAR-T therapy.
To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device physiological monitoring
Arm Type
Experimental
Arm Description
Patients will receive wearable sensor devices (Biostrap arm band)
Arm Title
Microsampling
Arm Type
No Intervention
Arm Description
Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.
Arm Title
Biostrap mobile App
Arm Type
No Intervention
Arm Description
Data collection from wearable sensor.
Intervention Type
Device
Intervention Name(s)
Biostrap arm band
Intervention Description
The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.
Primary Outcome Measure Information:
Title
Monitoring heart rate data
Time Frame
28 days
Title
Monitoring temperature data
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Microsampling
Description
microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm
Time Frame
28 days
Title
Safety of wearable devices
Description
Safety will be measured by skin irritation, rash. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices
Time Frame
28 days
Title
Safety of the microsampling device
Description
Microsampling will be measured by process such as minor bruising, bleeding, or infection. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must be in the process of undergoing cancer cell therapy at Stanford University.
Adults > 18 years
Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
English speaking
Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection
Exclusion Criteria:
In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharan Claire
Phone
650-721-4091
Email
sharanclaire@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surbhi Sidana
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharan Claire
Phone
650-721-4091
Email
sharanclaire@stanford.edu
First Name & Middle Initial & Last Name & Degree
Surbhi Sidana, MD
First Name & Middle Initial & Last Name & Degree
Michael P. Snyder, PhD
First Name & Middle Initial & Last Name & Degree
David Miklos, MD, PhD
First Name & Middle Initial & Last Name & Degree
Matthew Frank, MD, PhD
First Name & Middle Initial & Last Name & Degree
Theresa Latchford, MS
First Name & Middle Initial & Last Name & Degree
Ryan Kellogg, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
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