Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2022-07-07

Brief Summary

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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):

1. To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
2. To generate comprehensive multiomic profile analysis following CAR-T therapy.
3. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.

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Detailed Description

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Conditions

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Hodgkin Lymphoma Non Hodgkin Lymphoma Leukemia Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAR-T patients monitored with wearable devices and microsampling

All participants will receive wearable sensors, provide blood microsamples, and use the Biostrap mobile app for data capture. These are observational data collection tools applied to the entire cohort.

No interventions assigned to this group

Eligibility Criteria

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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