RECRUITING

Liquid Biopsy Based NGS in Newly Diagnosed NSCLC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study expands the application of an electronic health record (EHR) "nudge" used to prompt physicians' clinical practice to order molecular testing at the time of initial diagnosis for patients with specific types of advanced lung cancer. The primary goal is to have these test results available prior to starting treatment so that physicians can make molecularly-informed treatment decisions. The second goal is to better understand factors that contribute to whether or not the EHR-nudge implementation is successful.

Official Title

iNUDGE: INtegration of liqUiD Biopsy Based Next Generation Gene sEquencing in Newly Diagnosed NSCLC - A Stepped Wedge Cluster Randomized Clinical Trial

Quick Facts

Study Start:2023-06-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05853887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants must be seen at Lancaster General Health (LGH), Penn Presbyterian Medical Center (PPMC), Penn Medicine Cherry Hill (PMCH), Penn Medicine Princeton Health (PMPH), Penn Medicine Voorhees (PMV) or Penn Medicine Washington Township (PMWT) for mNSq NSCLC.
  1. * Participants with incomplete staging information.
  2. * Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.

Contacts and Locations

Study Contact

Meagan Hume, MPH
CONTACT
267-734-5455
Meagan.Hume@PennMedicine.upenn.edu

Principal Investigator

Charu Aggarwal, MD, MPH
PRINCIPAL_INVESTIGATOR
Penn Medicine

Study Locations (Sites)

Penn Medicine Cherry Hill
Cherry Hill, New Jersey, 08003
United States
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
United States
Penn Medicine Washington Township
Sewell, New Jersey, 08080
United States
Penn Medicine Voorhees
Voorhees, New Jersey, 08043
United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17602
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Charu Aggarwal

  • Charu Aggarwal, MD, MPH, PRINCIPAL_INVESTIGATOR, Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-06-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Next Generation Sequencing
  • Liquid biopsy
  • Newly diagnosed
  • Molecular testing
  • Plasma based next generation sequencing
  • Electronic health record
  • Nudge intervention
  • Targeted therapy
  • Behavioral economics

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer Metastatic
  • Newly Diagnosed NSCLC
  • Non-Squamous Non-Small Cell Neoplasm of Lung