Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

Más betegség

• Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
• Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded.
• Has angina with minimal exertion.

Egyéb

• The dominant nodule is ground glass or part solid as determined by CT scan.
• Has 5 or more nodules sized \>4 mm.
• The nodule sized \>6 to \<30 mm in diameter is a perifissural nodule.
• Is immunosuppressed.
• Has rheumatoid arthritis.
• Is currently pregnant or planning on becoming pregnant during this study.

• Is able to give signed informed consent and comply with study requirements.
• Is high risk for getting lung cancer:
  • ≥50 - 80 years of age.
  • current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.
• Has a \>6 to \<30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 12 weeks (3 months) of the prestudy baseline CT scan.
  • 3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \>6 to \<30 mm in diameter.
  • 4\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up.