COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-15
Study Completion:2022-07-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05123001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be in the process of undergoing cancer cell therapy at Stanford University.
  2. * Adults \> 18 years
  3. * Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
  4. * English speaking
  5. * Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection
  1. * In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.

Contacts and Locations

Principal Investigator

Surbhi Sidana
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Surbhi Sidana, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-15
Study Completion Date2022-07-07

Study Record Updates

Study Start Date2021-07-15
Study Completion Date2022-07-07

Terms related to this study

Additional Relevant MeSH Terms

  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Leukemia
  • Multiple Myeloma