Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06675643
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-Interventional study

Study Details

This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

Key Dates

Start date
Oct 14, 2024
Status verified
Feb 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Observational
    Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

Primary Outcome Measure

Incidence of grade 3-4 IR-adverse events [ Time Frame: Up to 100 days following treatment with IPI/NIVO ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Renee Bradshaw
507-284-2511
Svetomir N. Markovic, MD, PhD (PRINCIPAL_INVESTIGATOR)
Lisa A. Kottschade, APRN, CNP (PRINCIPAL_INVESTIGATOR)

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