CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
DELFI-L201
1 other identifier
observational
11,935
2 countries
67
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
March 19, 2026
March 1, 2026
4.2 years
March 23, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
Approximately 24 months
Secondary Outcomes (2)
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
Up to approximately 36 months
Adverse events (AEs) associated with the blood specimen collection.
Point in time blood collection (1 day) at enrollment
Study Arms (1)
Individuals with elevated-risk lung cancer (screening population)
Interventions
Subjects enrolled in DELFI-L201 will have blood specimens collected (\~30 mL) at enrollment or up to 30 days after enrollment.
Eligibility Criteria
Participants will be men and women, current or former smokers, ≥ 50 years of age who are scheduled for a standard-of-care screening chest CT scan.
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 Ă— 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Science 37 (nationwide digital enrollment)
Culver City, California, 90230, United States
Providence Facey Medical Foundation
Mission Hills, California, 91345, United States
Hoag Hospital
Newport Beach, California, 92663, United States
Paradigm Clinical Research Center, Inc.
Redding, California, 96001, United States
San Francisco VA
San Francisco, California, 94121, United States
Clinical Research of California LLC
Walnut Creek, California, 94598, United States
SCL Health Research Institute, St. Mary's
Grand Junction, Colorado, 81501, United States
Paradigm Clinical Research Center
Wheat Ridge, Colorado, 80033, United States
Stamford Health
Stamford, Connecticut, 06904, United States
Advanced Research
Boynton Beach, Florida, 33347, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
SIMEDHealth, LLC
Gainesville, Florida, 32607, United States
Galenus Group
Lehigh Acres, Florida, 33936, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
United Medical Research
Port Orange, Florida, 32127, United States
American Clinical Trials, LLC.
Acworth, Georgia, 30101, United States
Centricity Research Columbus Piedmont
Columbus, Georgia, 31904, United States
ClinCept, LLC
Columbus, Georgia, 31904, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313, United States
Centricity Research Gwinnett Pulmonology
Lawrenceville, Georgia, 30046, United States
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31326, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Ochsner
New Orleans, Louisiana, 70121, United States
Johns Hopkins
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336, United States
Minneapolis VA
Minneapolis, Minnesota, 55417, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hannibal Regional Healthcare System
Hannibal, Missouri, 63401, United States
Washington University
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
Internal Medicine Associate
Bridgeton, New Jersey, 08302, United States
CHRISTUS St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27705, United States
Durham VA
Durham, North Carolina, 27705, United States
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45069, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Clinical Research Associates of Central Pa, LLC
DuBois, Pennsylvania, 15801, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Pittsburgh VA Healthcare System
Pittsburgh, Pennsylvania, 15217, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
Ralph H Johnson VA
Charleston, South Carolina, 28401, United States
Medical University of South Carolina
Charleston, South Carolina, 29407, United States
LLM Research
Myrtle Beach, South Carolina, 29577, United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38120, United States
Greater Heights Memorial Pulmonary and Sleep
Houston, Texas, 77008, United States
Houston Pulmonary Sleep and Allergy Associates
Houston, Texas, 77070, United States
North Houston Cancer Clinics
Huntsville, Texas, 77340, United States
CHRISTUS Trinity Clinic Pulmonary Medicine
Irving, Texas, 75038, United States
R&H Clinical Research, Inc.
Katy, Texas, 77494, United States
Lumi Research
Kingwood, Texas, 77339, United States
Central Virginia VA Health System: Hunter Holmes McGuire
Richmond, Virginia, 23249, United States
UW Medicine Valley Medical Center
Renton, Washington, 98055, United States
Pan American Center for Oncology Trials
San Juan, 902, Puerto Rico
Biospecimen
Blood specimens will be de-identified and may be used to develop and evaluate performance of biomarker assays to detect cancers or other conditions, laboratory process improvements, and proficiency testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 1, 2022
Study Start
April 7, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03