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

Clinical Study

See If You're Eligible

Participant Discontinuation

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

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.


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.


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. 

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