NCT06659458

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2025

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

October 23, 2024

Last Update Submit

March 17, 2025

Conditions

Lung Cancer - Non Small CellEGFR Exon 19 Deletion Mutation

Keywords

Lung cancerEGFR gene

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to end of data analysis at 6 months

Study Arms (2)

EGFR Positive Lung Cancer

Subjects diagnosed with EGFR positive lung cancer

Other: blood drawOther: Gene sequencing

Healthy Subjects

Subjects who do not have a cancer diagnosis

Other: blood drawOther: Gene sequencing

Interventions

blood drawOTHER

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

EGFR Positive Lung CancerHealthy Subjects
Gene sequencingOTHER

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

EGFR Positive Lung CancerHealthy Subjects

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiologically born females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female adult subjects who have EGFR positive lung cancer

You may qualify if:

  • years old
  • Biologically born female
  • Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)
  • No cancer diagnosis (Arm 2-health control)

You may not qualify if:

  • less than 18 years of age
  • Biologically born male
  • Incarcerated at the time of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Blood Specimen CollectionBase Sequence

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Central Study Contacts

Cynthia Knox, MBA

CONTACT

225-765-3344Cynthia.Knox@fmolhs.org

Christine LeBoeuf, DNP

CONTACT

225-763-5956Christine.Leboeuf@fmolhs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 26, 2024

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 20, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available and shared with collaborators upon completion of gene sequencing analysis of the final subject and remain available until IRB closure.
Access Criteria
Only de-identified data will be shared with collaborators for the purpose of drawing conclusions and publication. Data will be sharing through a secure FileS system which is a HIPAA compliant platform offered by LSUHSC which limits access to only those for which the data is sent and does so in a secure manner.

Locations

US(1)