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Recruiting NCT06659458

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

Observational Lung Cancer - Non Small Cell EGFR Exon 19 Deletion Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood draw, Gene sequencing.
Who it may be relevant to
Registry conditions: Lung Cancer - Non Small Cell, EGFR Exon 19 Deletion Mutation. Basic parameters: 18 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Our Lady of the Lake Regional Medical Center — Baton Rouge

Identifiers

NCT: NCT06659458 · LSUHSCIRB_7781

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗