DNA Repair and Genetic Susceptibility to Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people with a second primary lung cancer with those who have only a first primary lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final. We will analyze your blood cells and DNA to measure the changes in several genes that we believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to repair itself.

Official Title
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DNA Repair and Genetic Susceptibility to Lung Cancer

Conditions
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Lung Cancer, Single Primary Lung Cancer, Second Primary Lung Cancer

Intervention / Treatment
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* Other: Blood draw and Questionnaires
* Other: Blood draw and Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases will be eligible for inclusion if: They have been diagnosed with a second primary lung cancer, and They speak English or a language for which we have a translated consent form, and They understand and agree to sign informed consent, and They agree to give us a blood sample, and They agree to give us a tissue sample when part of normal clinical procedures, and They agree to complete the study questionnaires, and They agree to have their pathology information reviewed. This could include biopsy specimens. Controls will be eligible for inclusion if They have been diagnosed with a first primary lung cancer, and They speak English or a language for which we have a translated consent form, and They understand and agree to sign informed consent, and They agree to give us a blood sample, and They agree to give us a tissue sample when part of normal clinical procedures, and They agree to complete the study questionnaires, They agree to have their pathology information reviewed. This will could include biopsy specimens. Exclusion Criteria: Subjects who do not meet the inclusion criteria as either cases or controls will not be eligible for this study. Control subjects who have a history of another cancer, other than nonmelanoma skin cancer or a first primary lung cancer, will not be eligible for this study. Control subjects who otherwise meet the eligibility requirements above but who have had chemotherapy and/or are currently being treated with chemotherapy will be excluded from the functional assay, but not from the genotyping.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>second primary lung cancer | Other: Blood draw and Questionnaires<br>* Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.<br>|
| 2<br>single primary lung cancer | Other: Blood draw and Questionnaires<br>* Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To conduct a pilot study of the role of DNA repair in lung cancer subjects with high genetic risk - those with a second primary lung cancer - compared to subjects with only one lung cancer. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways. |  | conclusion of the study |