CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
- Conditions
- Lung Cancer
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT05306288
- Lead Sponsor
- Delfi Diagnostics Inc.
- Brief Summary
CASCADE-LUNG is an event-driven, multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to determine the sensitivity and specificity of the Delfi Lung Cancer ScreeningTest (DLCST).
- Detailed Description
Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. DELFI identifies circulating tumor DNA (ctDNA) to detect cancer. 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 records reviews at two additional timepoints.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15000
-
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)
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals with elevated-risk lung cancer (screening population) Blood Sample Collection -
- Primary Outcome Measures
Name Time Method Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. Approximately 4 months
- Secondary Outcome Measures
Name Time Method Adverse events (AEs) associated with the blood specimen collection. Approximately 12 months Performance characteristics (sensitivity, specificity, PPV, NPV) of the Delfi DLCST based on results at the time of a 12-month follow-up. Approximately 12 months
Trial Locations
- Locations (74)
Hoag Hospital
🇺🇸Newport Beach, California, United States
Pittsburgh VA Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Pulmonary Sleep and Allergy Associates
🇺🇸Houston, Texas, United States
Minneapolis VA
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Durham VA
🇺🇸Durham, North Carolina, United States
Science 37 (nationwide digital enrollment)
🇺🇸Culver City, California, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
SCL Health Research Institute, St. Mary's
🇺🇸Grand Junction, Colorado, United States
Advanced Research
🇺🇸Boynton Beach, Florida, United States
Centricity Research Rincon Pulmonology
🇺🇸Rincon, Georgia, United States
Internal Medicine Associate
🇺🇸Bridgeton, New Jersey, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Pulmonary Research Institute of Southeast Michigan
🇺🇸Farmington Hills, Michigan, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Renew Health Clinical Research
🇺🇸Tampa, Florida, United States
MaineHealth Cancer Care - Biddeford
🇺🇸Biddeford, Maine, United States
American Clinical Trials, LLC.
🇺🇸Acworth, Georgia, United States
Stamford Health
🇺🇸Stamford, Connecticut, United States
Providence Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Paradigm Clinical Research Center
🇺🇸Wheat Ridge, Colorado, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
SIMEDHealth, LLC
🇺🇸Gainesville, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Centricity Research Columbus Piedmont
🇺🇸Columbus, Georgia, United States
Coastal Heritage Clinical Research
🇺🇸Hinesville, Georgia, United States
Greater Heights Memorial Pulmonary and Sleep
🇺🇸Houston, Texas, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Galenus Group
🇺🇸Lehigh Acres, Florida, United States
United Medical Research
🇺🇸Port Orange, Florida, United States
ClinCept, LLC
🇺🇸Columbus, Georgia, United States
Centricity Research Gwinnett Pulmonology
🇺🇸Lawrenceville, Georgia, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Hannibal Regional Healthcare System
🇺🇸Hannibal, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
North Houston Cancer Clinics
🇺🇸Huntsville, Texas, United States
Lumi Research
🇺🇸Kingwood, Texas, United States
Clinical Research Associates of Central Pa, LLC
🇺🇸DuBois, Pennsylvania, United States
LLM Research
🇺🇸Myrtle Beach, South Carolina, United States
CHRISTUS Trinity Clinic Pulmonary Medicine
🇺🇸Irving, Texas, United States
Pan American Center for Oncology Trials
🇵🇷San Juan, Puerto Rico
Coastal Carolina Health Care, P.A.
🇺🇸New Bern, North Carolina, United States
Baptist Clinical Research Institute
🇺🇸Memphis, Tennessee, United States
R&H Clinical Research, Inc.
🇺🇸Katy, Texas, United States
UW Medicine Valley Medical Center
🇺🇸Renton, Washington, United States
San Francisco VA
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Northwest Research Center
🇺🇸Portland, Oregon, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Ochsner
🇺🇸New Orleans, Louisiana, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Ralph H Johnson VA
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Central Virginia VA Health System: Hunter Holmes McGuire
🇺🇸Richmond, Virginia, United States
Paradigm Clinical Research Center, Inc.
🇺🇸Redding, California, United States
Clinical Research of California LLC
🇺🇸Walnut Creek, California, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Lung Health Services
🇺🇸Lansdale, Pennsylvania, United States
St. Clair Healthcare
🇺🇸Morehead, Kentucky, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
CHRISTUS St. Vincent Regional Medical Center
🇺🇸Santa Fe, New Mexico, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States