DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
NCT ID: NCT04825834
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2992 participants
OBSERVATIONAL
2021-03-22
2025-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis
Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.
Individuals eligible for Lung Cancer screening with no cancer diagnosis
Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.
Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis
Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.
Interventions
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Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.
Eligibility Criteria
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Inclusion Criteria
1. Ability to understand and provide written informed consent
2. Age ≥ 50 years
3. Current or Former Smoker
4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)
Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
AND
6. Meet one of the criteria below:
1. No suspected or confirmed lung cancer diagnosis OR
2. Suspected of lung cancer OR
3. Confirmed, untreated lung cancer
Inclusion Group 2: High Risk Patients that meet the following criteria:
7. Pathologic confirmed, invasive non-lung cancer diagnosis, originating from the esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, skin (excluding cutaneous basal cell and squamous cell carcinoma) kidney, or liver, with no prior systemic therapy, definitive therapy, radiation, or surgical resection.
OR Clinically confirmed invasive non-lung cancer diagnosis originating from the pancreas, kidney, or liver, based on imaging and clinical judgment with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.
OR Clinically (based on imaging and clinical judgment) or pathologically confirmed non-invasive or invasive bladder cancer with planned treatment and no prior systemic therapy, definitive therapy, radiation or surgical resection.
Exclusion Criteria
1. Prior systemic therapy, definitive therapy, radiation, or surgical resection for cancer within one year prior to enrollment (with the exception of organ biopsies or surgery for non-melanoma skin cancer)
2. Any history of hematologic malignancies or myelodysplasia
3. Any history of organ tissue transplantation
4. Any history of blood product transfusion
5. Current pregnancy
6. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
7. Prior systemic therapy, definitive therapy, radiation, or surgical resection for the enrollment cancer diagnosis (with the exception of organ biopsies or surgery for non-melanoma skin cancer are not exclusionary)
8. Enrollment in any DELFI sponsored study
50 Years
ALL
No
Sponsors
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Delfi Diagnostics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Mazzone, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Luke RG Pike, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Central Alabama Research
Homewood, Alabama, United States
Phoenix Medical Group
Peoria, Arizona, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Pulmonary Associates of Burlingame
Burlingame, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Centura Health
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
St. Mary's Hospital and Regional Medical
Grand Junction, Colorado, United States
Starling Physicians
New Britain, Connecticut, United States
Stamford Health
Stamford, Connecticut, United States
Baycare
Clearwater, Florida, United States
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, United States
Holy Cross Hospital Cancer Center
Fort Lauderdale, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Charter Research - The Villages
Orlando, Florida, United States
Millennium Physicians Group, LLC
Port Charlotte, Florida, United States
Charter Research - The Villages
The Villages, Florida, United States
Pulmonary and Sleep Specialists of Northeast Georgia - Dacula
Dacula, Georgia, United States
Christie Clinic
Champaign, Illinois, United States
Duly Health and Care
Joliet, Illinois, United States
Edward-Elmhurst Healthcare
Naperville, Illinois, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Louisville Pulmonary Care, PLLC
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Gulfport
Gulfport, Mississippi, United States
Washington University at St. Louis
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Holy Name Pulmonary Associates
Englewood, New Jersey, United States
Atlantic Digestive Health Institute
Morristown, New Jersey, United States
Oncology Hematology Specialists
Mountain Lakes, New Jersey, United States
MedCorps Asthma and Pulmonary Specialists - Sewell
Sewell, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Northwell Health
New York, New York, United States
CHEAR Center LLC
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Piedmont Healthcare
Statesville, North Carolina, United States
Wilmington Health
Wilmington, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Austin Regional Clinic ARC Clinical Research at Wilson Parke
Austin, Texas, United States
Premier Family Physicians
Austin, Texas, United States
Pulmonary Critical Care & Sleep Associates, P.A.
Conroe, Texas, United States
Huntsville Research Institute, LLC
Huntsville, Texas, United States
ProHealth Care
Waukesha, Wisconsin, United States
Pan American Center for Oncology Trials
San Juan, , Puerto Rico
Countries
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References
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Mazzone PJ, Bach PB, Carey J, Schonewolf CA, Bognar K, Ahluwalia MS, Cruz-Correa M, Gierada D, Kotagiri S, Lloyd K, Maldonado F, Ortendahl JD, Sequist LV, Silvestri GA, Tanner N, Thompson JC, Vachani A, Wong KK, Zaidi AH, Catallini J, Gershman A, Lumbard K, Millberg LK, Nawrocki J, Portwood C, Rangnekar A, Sheridan CC, Trivedi N, Wu T, Zong Y, Cotton L, Ryan A, Cisar C, Leal A, Dracopoli N, Scharpf RB, Velculescu VE, Pike LRG. Clinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection. Cancer Discov. 2024 Nov 1;14(11):2224-2242. doi: 10.1158/2159-8290.CD-24-0519.
Other Identifiers
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DELFI-L101 Study
Identifier Type: -
Identifier Source: org_study_id
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