DELFI – Randomize Now

CASCADE-LUNG:

Cancer Screening Assay using DELFI; A Clinical Validation Study in Lung

Clinical Study

See If You're Eligible

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)

Participant Discontinuation

Participants may be discontinued from the study for any of the following reasons:

Voluntary withdrawal of consent to participate by the participant at any time during the study
Blood specimen not provided
Blood specimen provided but unacceptable
Enrollment chest CT scan not completed
Death

Purpose of Study

For the purposes of disposition, duration of study participation will be from enrollment to completion of the 12-Month Follow-up Visit, approximately 12-13 months.

Primary

To determine the sensitivity and specificity of the DLCST for detection of lung cancer, using the reference method of chest CT at enrollment with histopathological diagnosis within 4 months of the reference scan.

Secondary

To evaluate the sensitivity and specificity of the DLCST to detect lung cancer in clinically relevant subgroups of interest (e.g., stage, nodule size, subtype, histology, initial or annual follow-up chest CT scan, lesion location, age groups, biological sex, race/ethnicity, etc.).

Study Procedures

Enrollment into the study will occur after informed consent and eligibility is confirmed. Blood specimens (~ 30 mL) will be collected on the same day as enrollment preferably or up to 30 days after enrollment. Participants will undergo a screening chest CT scan within approximately 30 days after enrollment. Medical record review will be completed at the 4-Month Follow-up Visit for participants with suspicious lung nodule(s) identified on the enrollment chest CT scan.