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

Running, not enrolling

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT05306288

Run by

Delfi Diagnostics Inc.

People needed

11935

Starts

2022-04-07

Expected to finish

2026-10-30

Last updated by the study team

2026-03-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects
• 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)

You may not qualify if…

• All subjects
• Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment
• Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies)
• Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment
• Any history of organ tissue transplantation
• Any history of blood product transfusion within 120 days prior to enrollment
• Current pregnancy
• Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
• Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics

Where it is running

• Science 37 (nationwide digital enrollment) — Culver City, California, United States
• Providence Facey Medical Foundation — Mission Hills, California, United States
• Hoag Hospital — Newport Beach, California, United States
• Paradigm Clinical Research Center, Inc. — Redding, California, United States
• San Francisco VA — San Francisco, California, United States
• Clinical Research of California LLC — Walnut Creek, California, United States
• SCL Health Research Institute, St. Mary's — Grand Junction, Colorado, United States
• Paradigm Clinical Research Center — Wheat Ridge, Colorado, United States
• Stamford Health — Stamford, Connecticut, United States
• Advanced Research — Boynton Beach, Florida, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• SIMEDHealth, LLC — Gainesville, Florida, United States
• Galenus Group — Lehigh Acres, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• United Medical Research — Port Orange, Florida, United States
• American Clinical Trials, LLC. — Acworth, Georgia, United States
• Centricity Research Columbus Piedmont — Columbus, Georgia, United States
• ClinCept, LLC — Columbus, Georgia, United States
• Coastal Heritage Clinical Research — Hinesville, Georgia, United States
• Centricity Research Gwinnett Pulmonology — Lawrenceville, Georgia, United States
• Centricity Research Rincon Pulmonology — Rincon, Georgia, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• Cullman Clinical Trials — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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