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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00603 | Registry Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Monitoring heart rate data | Defined as ≥70% of patients able to wear at least one sensor device for ≥50% of the days from CAR-T infusion (Day 0) to Day 28. Each day is counted if ≥12 hours of data are captured. | 28 days |
| Monitoring temperature data | Proportion of patients able to wear at least one sensor device for ≥50% of days from Day 0 (CAR-T infusion) through Day 28, with ≥12 hours/day of usable data collected (temperature, heart rate). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of microsampling | microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm | 28 days |
| 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 |
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Inclusion Criteria:
Participant must be in the process of undergoing cancer cell therapy at Stanford University.
Exclusion Criteria:
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Adult patients (≥18 years) receiving standard-of-care CAR-T cell therapy at Stanford University. Participants must be English-speaking and able, with caregiver assistance, to use wearable monitoring devices and perform blood microsampling. Up to 15 patients will be enrolled in this pilot study.
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| Name | Affiliation | Role |
|---|---|---|
| Surbhi Sidana | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| 28 days |
| 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 | 28 days |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |