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

NCT ID: NCT06659458

Condition: Lung Cancer - Non Small Cell
EGFR Exon 19 Deletion Mutation

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Lung cancer
EGFR gene

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: blood draw
Description: A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.
Arm group label: EGFR Positive Lung Cancer
Arm group label: Healthy Subjects

Intervention type: Other
Intervention name: Gene sequencing
Description: Subjects will have their DNA sequenced within and around the EGFR gene.
Arm group label: EGFR Positive Lung Cancer
Arm group label: Healthy Subjects

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.

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Biologically born females

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Our Lady of the Lake Regional Medical Center

Address:
City: Baton Rouge
Zip: 70808
Country: United States

Start date: January 1, 2025

Completion date: December 31, 2025

Lead sponsor:
Agency: Our Lady of the Lake Hospital
Agency class: Other

Source: Our Lady of the Lake Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06659458

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