Recruiting

Long-read Sequencing

Sponsor:

Our Lady of the Lake Hospital

Code:

NCT06659458

Conditions

Lung Cancer - Non Small Cell

EGFR Exon 19 Deletion Mutation

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

blood draw

Gene sequencing

Study Details

Brief summary:

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.

Conditions

Lung Cancer - Non Small Cell

EGFR Exon 19 Deletion Mutation

Study ID

NCT06659458

Start date

Jan 1, 2025

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

EGFR Positive Lung Cancer

Subjects diagnosed with EGFR positive lung cancer

Healthy Subjects

Subjects who do not have a cancer diagnosis

Interventions

blood draw

A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.

Gene sequencing

Subjects will have their DNA sequenced within and around the EGFR gene.

Primary outcome measure

  • Differences in DNA sequence of EGFR gene [ Time Frame: From enrollment to end of data analysis at 6 months ]

Central Contacts and Locations

Central contacts

Locations

Our Lady of the Lake Regional Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

More Information

Sponsor

Our Lady of the Lake Hospital

Last update posted

Mar 20, 2025

Last verified

Oct, 2024

Keywords

  • Lung cancer
  • EGFR gene

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Our Lady of the Lake Hospital on 2025-03-20.