Cohort B for Epidermal Growth Factor Receptor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Virginia, Charlottesville, VA
Epidermal Growth Factor Receptor+4 More
RX Cap - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

In this study, patients who are taking oral tyrosine kinase inhibitor (TKI) therapy for lung cancer will be asked to participate in a remote monitoring system for up to 24 weeks. The system will include: a smartphone application (app) developed at the University of Virginia called Sensus. Sensus will be downloaded to the participant's smartphone. The app will collect active data (such as through surveys) and passive data (such as accelerometer data). a fitness watch called a Fitbit will be given to the participant to be used during the study. The Fitbit will collect information such as steps and average heart rate. a smart pill cap called RX Cap will be given to the participant to be used during the study. The pill cap will collect information about how often a pill bottle is opened. The study will also involve paper surveys that are taken by the participant during clinic visits. Symptoms related to TKI therapy will be recorded by an investigator in the clinic. The study results will be used to guide development of a real-time symptom monitoring system, with the ultimate goal of improving TKI symptom response and quality of life.

Eligible Conditions

  • Epidermal Growth Factor Receptor
  • ALK Gene Mutation
  • Lung Cancers
  • EGFR Gene Mutations

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Epidermal Growth Factor Receptor

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 24 Weeks

24 Weeks
Estimate frequency and severity of adverse events
Feasibility of using the remote system to capture symptoms associated with TKI administration.

Trial Safety

Safety Progress

1 of 3

Other trials for Epidermal Growth Factor Receptor

Trial Design

2 Treatment Groups

Cohort B
1 of 2
Cohort A
1 of 2
Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: Cohort B · No Placebo Group · N/A

Cohort BExperimental Group · 4 Interventions: RX Cap, Sensus Smartwatch Application, Fitbit Sense, Surveys · Intervention Types: Device, Other, Device, Other
Cohort AExperimental Group · 4 Interventions: RX Cap, Sensus Smartwatch Application, Fitbit Sense, Surveys · Intervention Types: Device, Other, Device, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Trial Background

Ryan Gentzler, MD
Principal Investigator
University of Virginia
Closest Location: University of Virginia · Charlottesville, VA
Photo of university of virginia  1Photo of university of virginia  2Photo of university of virginia  3
2004First Recorded Clinical Trial
1 TrialsResearching Epidermal Growth Factor Receptor
526 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a smartphone or tablet.
You are willing to comply with all study procedures and are available for the duration of the study.
You are at least 18 years of age.
You have a diagnosis of lung cancer with an oncogenic driver mutation in EGFR or ALK.
You are able to download and use a smart device application for the purposes of this study
You must have the ability to access the Internet during the course of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.