CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung

Inclusion Criteria:

All subjects

Ability to understand and provide written informed consent
Age ≥ 50 years
Current or former smoker
≥ 20 pack-years (pack years = number of packs per day × number of years smoked)
An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan)

Exclusion Criteria:

All subjects

Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment
Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies)
Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment
Any history of organ tissue transplantation
Any history of blood product transfusion within 120 days prior to enrollment
Current pregnancy
Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
Past or current participation in any clinical study sponsored by Delfi Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by Delfi Diagnostics