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Liquid Biopsy NGS Prompt for Lung Cancer (iNUDGE Trial)
N/A
Recruiting
Led By Charu Aggarwal, MD, MPH
Research Sponsored by Charu Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a histological, or cytological diagnosis of metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC) who have not yet received systemic treatment for metastatic disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured up to 1 year from the time of randomization to death from any cause
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a way to use health records to prompt doctors to order molecular tests for lung cancer so they can provide better treatment. It also looks at how successful the prompt is.
Who is the study for?
This trial is for adults with a specific lung cancer type called metastatic non-squamous NSCLC, who haven't started treatment. They must be diagnosed at certain Penn Medicine locations. Pregnant women, children, and prisoners are excluded.
What is being tested?
The study tests an 'EHR-nudge' prompting doctors to order molecular testing when diagnosing advanced lung cancer. The aim is to use test results for informed treatment decisions and understand the nudge's effectiveness.
What are the potential side effects?
Since this trial focuses on improving diagnostic processes rather than testing a drug or therapy, it does not directly involve side effects related to medical interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of lung cancer called non-squamous NSCLC and haven't been treated for it since it spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured up to 1 year from the time of randomization to death from any cause
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured up to 1 year from the time of randomization to death from any cause
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC
Secondary study objectives
Completion of comprehensive molecular testing & modality used
Overall survival
Reasons for failure to complete comprehensive molecular testing
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Penn Presbyterian Medical CenterExperimental Treatment1 Intervention
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
Group II: Penn Medicine New JerseyExperimental Treatment1 Intervention
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
Group III: Penn Medicine Lancaster General HealthExperimental Treatment1 Intervention
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
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Who is running the clinical trial?
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,719 Total Patients Enrolled
Charu AggarwalLead Sponsor
Charu Aggarwal, MD, MPHPrincipal InvestigatorPenn Medicine
2 Previous Clinical Trials
217 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of lung cancer called non-squamous NSCLC and haven't been treated for it since it spread.
Research Study Groups:
This trial has the following groups:- Group 1: Penn Medicine New Jersey
- Group 2: Penn Presbyterian Medical Center
- Group 3: Penn Medicine Lancaster General Health
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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