Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

Study Overview
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Brief Summary
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The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.

Detailed Description
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Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.

Official Title
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2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

Conditions
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Healthy

Intervention / Treatment
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* Other: Blood Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female, 50 years of age or older. Subject meets one of two lung cancer screening criteria below. Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules). Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded). Prior history of cancer within the past 5 years except for non-melanoma skin cancer. Prior removal of the lung, excluding percutaneous lung biopsy. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer Screening Patients - No Nodules<br>Subjects in an low dose CT screening program that present no nodules. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.<br>|
| Lung Cancer Screening Patients - Nodules<br>Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Identification | Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer | 27 months |