Wearable Sensors for Blood Cancers

Overseen By Sharan Claire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearable sensors can monitor changes in patients with blood cancer undergoing CAR-T cell therapy. The focus is on finding better ways to detect and manage side effects like Cytokine Release Syndrome (a severe immune reaction) and neurotoxicity (nerve damage). Participants will wear a Biostrap arm band, a wearable sensor, to collect data, which researchers will combine with other health information. Individuals currently receiving cancer cell therapy at Stanford University who can use wearable devices might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that wearable sensors are safe for monitoring CAR-T therapy patients?

Research has shown that wearable sensors like the Biostrap arm band are generally safe. Designed to track health information without causing harm, these devices are well-tolerated, as studies have found that users rarely experience negative side effects. The primary purpose of these sensors is to monitor bodily changes, aiding in better health management. No major reports of problems related to the Biostrap arm band have emerged, indicating that most people should not encounter issues while wearing this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about wearable sensors for blood cancers because these devices offer a unique way to monitor patients' health in real-time. Unlike traditional methods that require frequent hospital visits for blood tests and physical exams, the Biostrap arm band continuously tracks physiological data like heart rate and oxygen levels. This real-time data collection allows for more responsive care, potentially catching complications earlier and tailoring treatments more effectively. Additionally, the integration with a mobile app makes it easier for both patients and healthcare providers to access and analyze health information, enhancing the overall management of the condition.

What evidence suggests that wearable sensors are effective for monitoring blood cancers?

Research has shown that wearable sensors, such as the Biostrap arm band used in this trial, effectively monitor patients receiving CAR-T cell therapy for blood cancers. These devices detect important body changes, crucial for managing side effects like Cytokine Release Syndrome (a severe immune reaction) and nerve damage. Studies have found that patients remain comfortable wearing these devices, even during intense cancer treatments. By collecting continuous data, wearable sensors can identify when patients need extra care, leading to better management of side effects and improved overall patient care. ^{1 2 3 6 7}

Who Is on the Research Team?

Surbhi Sidana, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Multiple Myeloma, Lymphoma, or Leukemia who are undergoing CAR-T cell therapy at Stanford University. Participants must speak English and be able to use wearable devices and collect blood samples with the help of a caregiver.

Inclusion Criteria

My treatment can target any cancer cell type.

I am over 18 years old.

You are receiving cancer treatment at Stanford University.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants undergo conditioning chemotherapy prior to CAR-T cell therapy

1 week

Daily visits (in-person) while in hospital

CAR-T Cell Therapy

Participants receive CAR-T cell therapy and are monitored for physiological and molecular changes

4 weeks

Daily monitoring (in-person) while in hospital, wearable sensor data collection

Follow-up

Participants are monitored for safety and effectiveness after CAR-T cell therapy, including adverse events management

4 weeks

Outpatient visits and wearable sensor data collection

What Are the Treatments Tested in This Trial?

Interventions

• Biostrap arm band

Trial Overview The study tests if a Biostrap arm band can accurately monitor changes in patients' bodies during CAR-T therapy to manage side effects better. It also involves analyzing biological data (multiomic profile) alongside sensor and clinical data.

How Is the Trial Designed?

Group I: Device physiological monitoring Experimental Treatment 1 Intervention

Patients will receive wearable sensor devices (Biostrap arm band)

Group II: Microsampling Active Control 1 Intervention

Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.

Group III: Biostrap mobile App Active Control 1 Intervention

Data collection from wearable sensor.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A new battery-free, wireless implantable device made entirely of bioresorbable materials can monitor internal body temperatures without the need for surgical extraction, reducing infection risks associated with traditional implants.

In tests on rat models, these devices operated stably for up to 4 days, showing promise for applications in monitoring healing processes and managing thermal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioresorbable, Wireless, Passive Sensors as Temporary Implants for Monitoring Regional Body Temperature. Lu, D., Yan, Y., Avila, R., et al.[2021]

The composite microneedle array electrode (CMAE) is a novel device that can simultaneously monitor body temperature and bio-signals, showing excellent mechanical properties by successfully piercing porcine skin 100 times without damage.

CMAE measurements of body temperature closely match those from clinical thermometers, and it offers a more convenient method for monitoring bio-signals compared to traditional electrodes, as it eliminates the need for skin preparation and gel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabrication of Composite Microneedle Array Electrode for Temperature and Bio-Signal Monitoring. Sun, Y., Ren, L., Jiang, L., et al.[2018]

Biosensors have advanced significantly since their inception in 1962, and they are now being used in clinical settings, particularly for diagnosing and treating hematological cancers like acute myeloid leukemia and chronic myeloid leukemia.

Recent developments include biosensors that assess the effectiveness of cancer treatments, such as cytarabine and imatinib, which could lead to more personalized and effective treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosensors in clinical practice: focus on oncohematology. Fracchiolla, NS., Artuso, S., Cortelezzi, A.[2021]

A novel approach using flexible wearable electronics and injectable nanoparticles can effectively capture and eliminate circulating tumor cells (CTCs) from the bloodstream, potentially disrupting metastasis.

The system demonstrated a high capture efficiency of 72.31% for CTCs in a simulated blood circulation model, and the nanoparticles can induce CTC death within 10 minutes by rapidly increasing temperature when activated by light from embedded LEDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A flexible wearable device coupled with injectable Fe3O4 nanoparticles for capturing circulating tumor cells and triggering their deaths. Li, Y., Liu, X., Zhang, Y., et al.[2023]

A new miniaturized sensor system has been developed that can be integrated into vascular stents to monitor in-stent restenosis (ISR), which is a common complication after stent placement.

This sensor can detect different cell types involved in ISR and differentiate between blood and blood clots, providing valuable real-time information in a more realistic physiological environment compared to previous laboratory methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Cardiovascular Stent Complications Using Self-Reporting Biosensors for Noninvasive Detection of Disease. Hoare, D., Tsiamis, A., Marland, JRK., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-a0c50

Wearable Sensors for Blood Cancers The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35025669/

Feasibility of Wearable-Based Remote Monitoring in ... Feasibility of Wearable-Based Remote Monitoring in Patients During Intensive Treatment for Aggressive Hematologic Malignancies. JCO Clin Cancer Inform. 2022 ...

3. biostrap.com biostrap.com/

Biostrap - Wearable Health Monitoring Platform For B2B Biostrap offers an end-to-end wearable health monitoring solution for personalized care that helps to achieve the best health outcomes for your patients.

4. curetoday.com curetoday.com/view/wearable-remote-monitoring-device-may-help-patients-with-blood-cancers-identify-when-to-seek-follow-up-care

Wearable Remote Monitoring Device May Help Patients ... ... Cancer Informatics, also showed that patients tolerated wearing the device. Intensive treatment protocols for hematologic malignancies such ...

5. biostrap.com biostrap.com/research/

Research Empowering investigators & research organizations with comprehensive tools to transform health data collection and analysis in clinical studies.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05123001

Study Details | NCT05123001 | Wearable Sensors and ... The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379872/

Use of wearable biosensor technology to minimize sleep ... Patients with hematological malignancies frequently suffer from sleep disruptions during hospitalization, primarily due to frequent night-time interventions ...