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

NCT ID: NCT06659458

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer - Non Small Cell EGFR Exon 19 Deletion Mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGFR Positive Lung Cancer

Subjects diagnosed with EGFR positive lung cancer

blood draw

Intervention Type OTHER

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

Gene sequencing

Intervention Type OTHER

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

Healthy Subjects

Subjects who do not have a cancer diagnosis

blood draw

Intervention Type OTHER

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

Gene sequencing

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood draw

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

Intervention Type OTHER

Gene sequencing

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Our Lady of the Lake Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leslie Son

Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cynthia Knox, MBA

Role: CONTACT

225-765-3344

Christine LeBoeuf, DNP

Role: CONTACT

225-763-5956

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LSUHSCIRB_7781

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.