Clinical Trials

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 X number of years smoked)

Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:

• Prior thoracic imaging (computed tomography (CT)) within 12 months of enrollment OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment AND
• Meet one of the criteria below: a) No suspected or confirmed lung cancer diagnosis as defined by:
  • No clinical and/or radiological findings that indicate suspicion of lung cancer diagnosis (i.e., no lung nodules, <6mm lung nodules, ≥6mm lung nodules with no significant change from prior CT scan); OR
  • Suspected of lung cancer as defined by:
  • Radiological finding and/or clinical evaluation that indicates suspicion of lung cancer diagnosis (i.e., suspicious lung nodule(s) ≥6mm or Lung-RADS 3/4 for first-time CT scan patients and newly suspicious lung nodule(s) ≥ 6mm or Lung-RADS 3/4 identified within 6 months prior to enrollment for follow-up and surveillance CT scan patients). Subjects must have not received therapy prior to blood collection; OR
  • Confirmed, untreated lung cancer as defined by:
  • Pathologic diagnosis of lung cancer with no prior systemic therapy, definitive therapy, radiation, or surgical resection for any lesion.

Inclusion Group 2: High Risk Patients that meet the following criteria:

• Pathologic confirmed, invasive non-lung cancer diagnosis, originating from esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, bladder, kidney, or liver, with no prior systemic therapy, definitive therapy, radiation, or surgical resection; OR
• Clinically confirmed invasive non-lung cancer diagnosis originating from the pancreas, kidney, or liver, based on imaging and clinical judgement with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.

Exclusion Criteria:

All Subjects:

• Prior systemic therapy, definitive therapy, radiation, or surgical resection for cancer within one year prior to enrollment (with the exception of organ biopsies or surgery for non-melanoma skin cancer).
• Any history of hematologic malignancies or myelodysplasia.
• Any history of organ tissue transplantation.
• 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 subject’s participation in the study.
• Prior systemic therapy.
• Prior systemic therapy, definitive therapy, radiation, or surgical resection for the enrollment cancer diagnosis (with the exception of organ biopsies or surgery for non-melanoma skin cancer are not exclusionary).
• Enrollment in the DELFI-L201 study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/15/23. Questions regarding updates should be directed to the study team contact.