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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR Positive Lung Cancer | Subjects diagnosed with EGFR positive lung cancer |
| |
| Healthy Subjects | Subjects who do not have a cancer diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood draw | Other | A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Biologically born females
Female adult subjects who have EGFR positive lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Knox, MBA | Contact | 225-765-3344 | Cynthia.Knox@fmolhs.org | |
| Christine LeBoeuf, DNP | Contact | 225-763-5956 | Christine.Leboeuf@fmolhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of the Lake Regional Medical Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
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.
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.
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.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001483 | Base Sequence |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Gene sequencing | Other | Subjects will have their DNA sequenced within and around the EGFR gene. |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |