DNA Evaluation of Fragments for Early Interception – Lung Cancer Training Study (DELFI-L101 Study)

Inclusion Criteria:

All Participants:

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 with computed tomography (CT) within 12 months of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)

OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)

AND

Meet one of the criteria below:

No suspected or confirmed lung cancer diagnosis OR
Suspected of lung cancer OR
Confirmed, untreated lung cancer

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

Pathologic confirmed, invasive non-lung cancer diagnosis, originating from the esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, skin (excluding cutaneous basal cell and squamous cell carcinoma) 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 judgment with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.

OR Clinically (based on imaging and clinical judgment) or pathologically confirmed non-invasive or invasive bladder cancer with planned treatment and no prior systemic therapy, definitive therapy, radiation or surgical resection.

Exclusion Criteria:

All Participants:

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
Any history of blood product transfusion
Current pregnancy
Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
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 any DELFI sponsored study