CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (NCT05306288)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).
Location: Cullman Clinical Trials — Cullman, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (67 Sites)
- Cullman Clinical Trials — Cullman, Alabama
- Science 37 (nationwide digital enrollment) — Culver City, California
- Providence Facey Medical Foundation — Mission Hills, California
- Hoag Hospital — Newport Beach, California
- Paradigm Clinical Research Center, Inc. — Redding, California
- San Francisco VA — San Francisco, California
- Clinical Research of California LLC — Walnut Creek, California
- SCL Health Research Institute, St. Mary's — Grand Junction, Colorado
- Paradigm Clinical Research Center — Wheat Ridge, Colorado
- Stamford Health — Stamford, Connecticut
- Advanced Research — Boynton Beach, Florida
- Morton Plant Hospital — Clearwater, Florida
- SIMEDHealth, LLC — Gainesville, Florida
- Galenus Group — Lehigh Acres, Florida
- Renstar Medical Research — Ocala, Florida
- United Medical Research — Port Orange, Florida
- American Clinical Trials, LLC. — Acworth, Georgia
- Centricity Research Columbus Piedmont — Columbus, Georgia
- ClinCept, LLC — Columbus, Georgia
- Coastal Heritage Clinical Research — Hinesville, Georgia
- Centricity Research Gwinnett Pulmonology — Lawrenceville, Georgia
- Centricity Research Rincon Pulmonology — Rincon, Georgia
- OSF Saint Francis Medical Center — Peoria, Illinois
- Springfield Clinic — Springfield, Illinois
- St. Elizabeth Healthcare — Edgewood, Kentucky
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.