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

Lab values

• 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

• 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)