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

NCT05306288 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 11935

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Delfi Diagnostics Inc.

    lead INDUSTRY

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2026-06-30
Completion
2026-10-30
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306288 on ClinicalTrials.gov