Lung Cancer - Non Small CellEGFR Lung CancNCT06659458
Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients
An observational study of Lung Cancer - Non Small Cell and EGFR Exon 19 Deletion Mutation, run by Our Lady of the Lake Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer - Non Small Cell, EGFR Exon 19 Deletion Mutation
- What is being tested?
- blood draw and Gene sequencing
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female adult subjects who have EGFR positive lung cancer
Who may be able to join
- 18-100 years old
- Biologically born female
- Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)
- No cancer diagnosis (Arm 2-health control)
Who cannot join
- less than 18 years of age
- Biologically born male
- Incarcerated at the time of participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
About this study
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.
- Being tested
- blood draw, Gene sequencing
- Keywords
- Lung cancer, EGFR gene
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.
Gene sequencingOther
Subjects will have their DNA sequenced within and around the EGFR gene.
| Study group | Role | What they receive |
|---|---|---|
| EGFR Positive Lung Cancer | Subjects diagnosed with EGFR positive lung cancer Receives: Other: blood draw; Other: Gene sequencing | |
| Healthy Subjects | Subjects who do not have a cancer diagnosis Receives: Other: blood draw; Other: Gene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in DNA sequence of EGFR gene
Subjects who have EGFR positive lung cancer will have their gene sequence compared to those that are EGFR negative and do not have lung cancer to look for differences in the sequence.
Measured: From enrollment to end of data analysis at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer - Non Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Son, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659458
- Sponsor's protocol ID
- LSUHSCIRB_7781
- Acronym
- EGFR Lung Canc
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The demographic variables of age, race and gender will be shared with our external collaborator at Louisiana State University, Dept of Chemical Engineering in order to draw broad conclusions about the sequencing data and to use these general categories for presentation and publication. Data will be de-identified upon sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06659458
- Acronym / sponsor ID
- EGFR Lung Canc / LSUHSCIRB_7781
- Keywords
- Lung cancer, EGFR gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR Positive Lung Cancer | – | Other: blood draw, Other: Gene sequencingSubjects diagnosed with EGFR positive lung cancer |
| Healthy Subjects | – | Other: blood draw, Other: Gene sequencingSubjects who do not have a cancer diagnosis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female adult subjects who have EGFR positive lung cancer
Key inclusion criteria (4 listed)
- 18-100 years old
- Biologically born female
- Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)
- No cancer diagnosis (Arm 2-health control)
Key exclusion criteria (3 listed)
- less than 18 years of age
- Biologically born male
- Incarcerated at the time of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawA 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA. | Other | EGFR Positive Lung Cancer, Healthy Subjects |
| Gene sequencingSubjects will have their DNA sequenced within and around the EGFR gene. | Other | EGFR Positive Lung Cancer, Healthy Subjects |
Primary outcome
Differences in DNA sequence of EGFR gene
Time frame: From enrollment to end of data analysis at 6 months
Subjects who have EGFR positive lung cancer will have their gene sequence compared to those that are EGFR negative and do not have lung cancer to look for differences in the sequence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Yes. The demographic variables of age, race and gender will be shared with our external collaborator at Louisiana State University, Dept of Chemical Engineering in order to draw broad conclusions about the sequencing data and to use these general categories for presentation and publication. Data will be de-identified upon sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer - Non Small Cell and EGFR Exon 19 Deletion Mutation, run by Our Lady of the Lake Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Knox, MBA (225-765-3344, Cynthia.Knox@fmolhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in DNA sequence of EGFR gene (time frame: From enrollment to end of data analysis at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.