Targeted Therapy
RX Cap for Lung Cancer
University of Virginia, Charlottesville, VA
Targeting 9 different conditionsRX Cap +3 moreN/ARecruitingLed by Ryan Gentzler, MDResearch Sponsored by University of VirginiaEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Owns a smartphone or tablet
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 weeks
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test a remote monitoring system for patients on TKI therapy for lung cancer, including a smartphone app, fitness watch, and smart pill cap.
Eligible Conditions
- Lung Cancer
- Epidermal Growth Factor Receptor Mutations
- Epidermal Growth Factor Receptor (EGFR)
- Gene Mutation
- BRAF Mutation
- ROS1 Gene Mutation
- Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a smartphone or tablet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of using the remote system to capture symptoms associated with TKI administration.
Secondary outcome measures
Estimate frequency and severity of adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment4 Interventions
Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.
Group II: Cohort AExperimental Treatment4 Interventions
Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.
Find a site
Who is running the clinical trial?
University of VirginiaLead Sponsor
721 Previous Clinical Trials
1,567,447 Total Patients Enrolled
Ryan Gentzler, MDPrincipal Investigator
University of VirginiaMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there limits to the number of volunteers in this research endeavor?
"Yes, the information available on clinicaltrials.gov reveals that this medical research is currently looking for participants; it was first posted 25th August 2022 and updated 26th August 2022. The trial requires 75 people to be enrolled from one medical site."
Answered by AI
Is enrollment still available for this clinical exploration?
"Clinicialtrials.gov reports that this medical trial is currently recruiting participants, and the study was originally posted on August 25th 2022 with its most recent revision taking place a day later."
Answered by AI
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