NCT05306288

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 11,935 (actual)
• Sponsor: Delfi Diagnostics Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

Summary

CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to demonstrate the performance characteristics, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DELFI Lung Cancer Screening Test (DLCST) for the detection of pathologically-confirmed lung cancer in a screening population using LDCT, pathology, and follow-up as the reference method.

Detailed description

DELFI identifies circulating fragments of DNA (cfDNA) and plasma biomarkers to detect cancer. Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. The study purpose is to validate the performance of the DELFI-based test for the detection of lung cancer among individuals eligible for routine lung cancer screening. Participants will have blood collected and medical record review at baseline and will have medical record reviews at additional timepoints.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	Blood Sample Collection	Subjects enrolled in DELFI-L201 will have blood specimens collected (\~30 mL) at enrollment or up to 30 days after enrollment.

Timeline

• Start date: 2022-04-07
• Primary completion: 2026-06-30
• Completion: 2026-10-30
• First posted: 2022-04-01
• Last updated: 2026-03-19

Locations

67 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study