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Targeted Therapy

Remote Monitoring System for Lung Cancer (Lung001 Trial)

N/A

Waitlist Available

Led By Ryan Gentzler, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of non-small cell lung cancer (NSCLC) with an actionable mutation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Lung001 Trial 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.

Who is the study for?

This trial is for adults over 18 with non-small cell lung cancer and specific gene mutations, who are taking or starting oral tyrosine kinase inhibitors. Participants need to be able to use a smartwatch app, own a smartphone or tablet, have WiFi or mobile network access, and commit to the study's duration.Check my eligibility

What is being tested?

The study tests a remote monitoring system using the Sensus app on smartphones, Fitbit watches for activity tracking, and RX Cap for medication adherence. It aims to track symptoms in real-time during TKI therapy over 24 weeks to improve treatment response and life quality.See study design

What are the potential side effects?

There are no direct side effects from the interventions being tested as they involve monitoring devices like an application and fitness watch. However, participants may experience discomfort or inconvenience related to frequent data collection.

Lung001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung cancer has a specific mutation that can be targeted with treatment.

Lung001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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

Lung001 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,001 Total Patients Enrolled

Ryan Gentzler, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Oral Targeted Therapies (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05370469 — N/A

Lung Cancer Research Study Groups: Cohort B, Cohort A

Lung Cancer Clinical Trial 2023: Oral Targeted Therapies Highlights & Side Effects. Trial Name: NCT05370469 — N/A

Oral Targeted Therapies (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370469 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies

Ryan Gentzler, MD 2022. "Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370469.