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NCT05370469 · ClinicalTrials.gov registry record · NA
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies
A NA study of Lung Cancer and EGFR Gene Mutation, sponsored by University of Virginia.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05370469: Active NA study of Lung Cancer and EGFR Gene Mutation, sponsored by University of Virginia.
NCT05370469 is a NA study of Lung Cancer and EGFR Gene Mutation that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 30 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05370469, a NA study of Lung Cancer and EGFR Gene Mutation, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.
Conditions Studied
Interventions
- OTHER Surveys
- OTHER Sensus Smartwatch Application
- DEVICE RX Cap
- DEVICE Fitbit Sense
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT05370469 still lists
NCT05370469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower).
The record links to 9 conditions, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Surveys is the first listed.
NCT05370469 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05370469 about?
NCT05370469 is a clinical study titled "Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies". 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 ...
What is the current status of trial NCT05370469?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-08-25. Estimated completion is 2026-05.
What conditions does trial NCT05370469 study?
This clinical trial studies the following conditions: Lung Cancer, EGFR Gene Mutation, EGFR, KRAS Mutation-Related Tumors, ALK Gene Mutation.
What interventions are being tested in trial NCT05370469?
The interventions under investigation include: Surveys (OTHER), Sensus Smartwatch Application (OTHER), RX Cap (DEVICE), Fitbit Sense (DEVICE).
Who is sponsoring clinical trial NCT05370469?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05370469 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05370469's enrollment target sits among peer trials
30 318th of 409 higher than 80 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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