Wearable Sensors for Blood Cancers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Non-compliance, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
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.
How does the wearable sensor treatment for blood cancers differ from other treatments?
This treatment is unique because it uses a flexible wearable device combined with injectable nanoparticles to capture and kill circulating tumor cells in the blood, which can help prevent cancer from spreading. Unlike traditional treatments, this approach directly targets cancer cells in the bloodstream using a non-invasive method.
12345Eligibility Criteria
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.Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Device physiological monitoringExperimental Treatment1 Intervention
Patients will receive wearable sensor devices (Biostrap arm band)
Group II: MicrosamplingActive Control1 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 AppActive Control1 Intervention
Data collection from wearable sensor.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
References
Bioresorbable, Wireless, Passive Sensors as Temporary Implants for Monitoring Regional Body Temperature. [2021]Measurements of regional internal body temperatures can yield important information in the diagnosis of immune response-related anomalies, for precisely managing the effects of hyperthermia and hypothermia therapies and monitoring other transient body processes such as those associated with wound healing. Current approaches rely on permanent implants that require extraction surgeries after the measurements are no longer needed. Emerging classes of bioresorbable sensors eliminate the requirements for extraction, but their use of percutaneous wires for data acquisition leads to risks for infection at the suture site. As an alternative, a battery-free, wireless implantable device is reported here, which is constructed entirely with bioresorbable materials for monitoring regional internal body temperatures over clinically relevant timeframes. Ultimately, these devices disappear completely in the body through natural processes. In vivo demonstrations indicate stable operation as subcutaneous and intracranial implants in rat models for up to 4 days. Potential applications include monitoring of healing cascades associated with surgical wounds, recovery processes following internal injuries, and the progression of thermal therapies for various conditions.
Biosensors in clinical practice: focus on oncohematology. [2021]Biosensors are devices that are capable of detecting specific biological analytes and converting their presence or concentration into some electrical, thermal, optical or other signal that can be easily analysed. The first biosensor was designed by Clark and Lyons in 1962 as a means of measuring glucose. Since then, much progress has been made and the applications of biosensors are today potentially boundless. This review is limited to their clinical applications, particularly in the field of oncohematology. Biosensors have recently been developed in order to improve the diagnosis and treatment of patients affected by hematological malignancies, such as the biosensor for assessing the in vitro pre-treatment efficacy of cytarabine in acute myeloid leukemia, and the fluorescence resonance energy transfer-based biosensor for assessing the efficacy of imatinib in chronic myeloid leukemia. The review also considers the challenges and future perspectives of biosensors in clinical practice.
A flexible wearable device coupled with injectable Fe3O4 nanoparticles for capturing circulating tumor cells and triggering their deaths. [2023]Elimination of circulating tumor cells (CTCs) in the blood can be an effective therapeutic approach to disrupt metastasis. Here, a strategy is proposed to implement flexible wearable electronics and injectable nanomaterials to disrupt the hematogenous transport of CTCs. A flexible device containing an origami magnetic membrane is used to attract Fe3O4@Au nanoparticles (NPs) that are surface modified with specific aptamers and intravenously injected into blood vessels, forming an invisible hand and fishing line/bait configuration to specifically capture CTCs through bonding with aptamers. Thereafter, thinned flexible AlGaAs LEDs in the device offer an average fluence of 15.75 mW mm-2 at a skin penetration depth of 1.5 mm, causing a rapid rise of temperature to 48 °C in the NPs and triggering CTC death in 10 min. The flexible device has been demonstrated for intravascular isolation and enrichment of CTCs with a capture efficiency of 72.31% after 10 cycles in a simulated blood circulation system based on a prosthetic upper limb. The fusion of nanomaterials and flexible electronics reveals an emerging field that utilizes wearable and flexible stimulators to activate biological effects offered by nanomaterials, leading to improved therapeutical effects and postoperative outcomes of diseases.
Predicting Cardiovascular Stent Complications Using Self-Reporting Biosensors for Noninvasive Detection of Disease. [2023]Self-reporting implantable medical devices are the future of cardiovascular healthcare. Cardiovascular complications such as blocked arteries that lead to the majority of heart attacks and strokes are frequently treated with inert metal stents that reopen affected vessels. Stents frequently re-block after deployment due to a wound response called in-stent restenosis (ISR). Herein, an implantable miniaturized sensor and telemetry system are developed that can detect this process, discern the different cell types associated with ISR, distinguish sub plaque components as demonstrated with ex vivo samples, and differentiate blood from blood clot, all on a silicon substrate making it suitable for integration onto a vascular stent. This work shows that microfabricated sensors can provide clinically relevant information in settings closer to physiological conditions than previous work with cultured cells.
Fabrication of Composite Microneedle Array Electrode for Temperature and Bio-Signal Monitoring. [2018]Body temperature and bio-signals are important health indicators that reflect the human health condition. However, monitoring these indexes is inconvenient and time-consuming, requires various instruments, and needs professional skill. In this study, a composite microneedle array electrode (CMAE) was designed and fabricated. It simultaneously detects body temperature and bio-signals. The CMAE consists of a 6 × 6 microneedles array with a height of 500 μm and a base diameter of 200 μm. Multiple insertion experiments indicate that the CMAE possesses excellent mechanical properties. The CMAE can pierce porcine skin 100 times without breaking or bending. A linear calibration relationship between temperature and voltage are experimentally obtained. Armpit temperature (35.8 °C) and forearm temperature (35.3 °C) are detected with the CMAE, and the measurements agree well with the data acquired with a clinical thermometer. Bio-signals including EII, ECG, and EMG are recorded and compared with those obtained by a commercial Ag/AgCl electrode. The CMAE continuously monitors bio-signals and is more convenient to apply because it does not require skin preparation and gel usage. The CMAE exhibits good potential for continuous and repetitive monitoring of body temperature and bio-signals.