Sponsors

Lead Sponsor

Integrated Diagnostics

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥ 40 years
•Smoking history: Never, Former, Current
•Subject undergoing diagnostic evaluation for a lung nodule
•Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
•Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
•Nodule(s) identified by CT scan previously not followed
•Subject willing to provide informed consent for the collection of blood specimens

Exclusion Criteria

•Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
•A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
•Current diagnosis of any cancer
•Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
•Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
•History of human immunodeficiency virus (HIV) or Hepatitis C

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