Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients (EGFR Lung Canc)

EGFR gene mutations are some of the most commonly occurring mutations in non-small cell lung cancer. Investigators have developed a DNA instability model that estimates a risk score to assess the likelihood of an individual acquiring a cancer-linked mutation. The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.

Study Overview

• Status: Recruiting
• Conditions: EGFR Exon 19 Deletion Mutation; Lung Cancer - Non Small Cell
• Intervention / Treatment: Other: blood draw; Other: Gene sequencing

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Knox, MBA; Phone Number: 225-765-3344; Email: Cynthia.Knox@fmolhs.org
• Study Contact Backup: Name: Christine LeBoeuf, DNP; Phone Number: 225-763-5956; Email: Christine.Leboeuf@fmolhs.org

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Our Lady of the Lake Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female adult subjects who have EGFR positive lung cancer

Description

Inclusion Criteria:

• 18-100 years old
• Biologically born female
• Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)
• No cancer diagnosis (Arm 2-health control)

Exclusion Criteria:

• less than 18 years of age
• Biologically born male
• Incarcerated at the time of participation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EGFR Positive Lung Cancer; Subjects diagnosed with EGFR positive lung cancer	Other: blood draw; A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.; Other: Gene sequencing; Subjects will have their DNA sequenced within and around the EGFR gene.
Healthy Subjects; Subjects who do not have a cancer diagnosis	Other: blood draw; A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.; Other: Gene sequencing; Subjects will have their DNA sequenced within and around the EGFR gene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in DNA sequence of EGFR gene	Subjects who have EGFR positive lung cancer will have their gene sequence compared to those that are EGFR negative and do not have lung cancer to look for differences in the sequence.	From enrollment to end of data analysis at 6 months

Collaborators and Investigators

• Sponsor: Our Lady of the Lake Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Lung cancer; EGFR gene
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LSUHSCIRB_7781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The demographic variables of age, race and gender will be shared with our external collaborator at Louisiana State University, Dept of Chemical Engineering in order to draw broad conclusions about the sequencing data and to use these general categories for presentation and publication. Data will be de-identified upon sharing.
• IPD Sharing Time Frame: The data will be available and shared with collaborators upon completion of gene sequencing analysis of the final subject and remain available until IRB closure.
• IPD Sharing Access Criteria: Only de-identified data will be shared with collaborators for the purpose of drawing conclusions and publication. Data will be sharing through a secure FileS system which is a HIPAA compliant platform offered by LSUHSC which limits access to only those for which the data is sent and does so in a secure manner.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No