Gene Sequencing for EGFR Positive Lung Cancer

(EGFR Lung Canc Trial)

Overseen By Christine LeBoeuf, DNP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Our Lady of the Lake Hospital

Disqualifiers: Under 18, Male, Incarcerated

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with non-small cell lung cancer that have EGFR gene mutations, as well as healthy volunteers. The goal is to compare their blood samples and genetic information.

Inclusion Criteria

I was assigned female at birth.

I have never been diagnosed with cancer.

My lung cancer is EGFR positive.

Exclusion Criteria

Incarcerated at the time of participation

I was born male.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Blood samples are collected from participants for gene sequencing analysis

1 week

1 visit (in-person)

Data Analysis

Gene sequences are analyzed to validate the risk assessment model

6 months

Follow-up

Participants are monitored for any updates or additional data collection needs

4 weeks

Treatment Details

Interventions

• Utilizing Long-read Sequencing

Trial Overview The study involves taking blood from participants and analyzing the genes related to EGFR. It aims to validate a model that predicts the risk of developing cancer-linked mutations in these genes.

Participant Groups

Group I: Healthy Subjects Experimental Treatment 2 Interventions

Subjects who do not have a cancer diagnosis

Group II: EGFR Positive Lung Cancer Experimental Treatment 2 Interventions

Subjects diagnosed with EGFR positive lung cancer

Who Is Running the Clinical Trial?

Our Lady of the Lake Hospital

Lead Sponsor

Trials

15

Recruited

900+