Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

Detailed Description
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Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.

Official Title
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Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Conditions
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Lung Cancer (Diagnosis)

Intervention / Treatment
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* Other: Blood Sample Collection
* Other: Blood Sample Collection
* Other: Blood Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Subjects: Subject is male or female, 35 years of age or older. Subject has at least one CT confirmed 6-30 mm nodule. 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. Suspicion of Cancer Subjects: Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure. Pathologically Confirmed Cancer Subjects: 4. Subject has pathologically confirmed lung cancer and is treatment naïve. Pulmonary Nodule Subjects: 4. Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT). Exclusion Criteria: All Subjects CT with IV contrast within 1 day [or 24 hours] of blood collection. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment. Prior removal of the lung, excluding percutaneous lung biopsy. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial. 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. Pathologically Confirmed Cancer Subjects: Biopsy within 7 days prior to blood collection. Unresolved bleeding as a result of biopsy at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 35 Years

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 |
| --- | --- |
| Pulmonary Nodules<br>Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution. A second blood draw will be collected at 12 months. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.<br>|
| CT Suspicion of Cancer<br>Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.<br>|
| Pathologically Confirmed Cancer<br>Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample. | Other: Blood Sample Collection<br>* Subjects participating in the study will have blood drawn at enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Identification | Screening subjects to find the appropriate methylation sites for the detection of lung cancer | Subjects could be followed for up to 27 months. |