DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)

NCT04825834 | Completed

• 1 other identifier: DELFI-L101 Study
• Study Type: observational
• Target: 2,992
• Locations: 2 countries
• Sites: 57

Brief Summary

The primary objective of this study, DELFI-L101, is to train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.

Conditions

Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Bladder Cancer; Kidney Cancer; Stomach Cancer; Colorectal Cancer; Pancreas Cancer; Liver Cancer; Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.

  Approximately 12 months

Secondary Outcomes (8)

• Accuracy (sensitivity and specificity) in clinical subgroups of interest

  Approximately 12 months

• Prevalence-based measures, including positive predictive value (PPV), negative predictive value (NPV), and number needed to screen (NNS)

  Approximately 12 months

• Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type)

  Approximately 12 months

• Adverse events (AEs) associated with the blood specimen collection

  Point in time of blood specimen collection (1day) at enrollment

• Expected distribution of the DELFI score in the intended use population and clinical subgroups of interest

  Approximately 12 months

Study Arms (3)

Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis

Other: Blood Sample Collection

Individuals eligible for Lung Cancer screening with no cancer diagnosis

Other: Blood Sample Collection

Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis

Other: Blood Sample Collection

Interventions

Blood Sample Collection OTHER

Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.

Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis; Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis; Individuals eligible for Lung Cancer screening with no cancer diagnosis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals ≥ 50 years of age who are eligible for lung cancer screening from medical, surgical, sub- specialty clinics, lung cancer screening, lung nodule, thoracic surgery, and chest clinic practices.

You may qualify if:

• All Participants:
• 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 X number of years smoked)
• AND
• Meet one of the criteria below:
• No suspected or confirmed lung cancer diagnosis OR
• Suspected of lung cancer OR
• Confirmed, untreated lung cancer
• 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.

You may not qualify if:

• All Participants:
• 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)
• Any history of hematologic malignancies or myelodysplasia
• Any history of organ tissue transplantation
• Any history of blood product transfusion
• Current pregnancy
• Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
• Enrollment in any DELFI sponsored study

Sponsors & Collaborators

• Delfi Diagnostics Inc.: lead

Study Sites (57)

Central Alabama Research

Homewood, Alabama, 35209, United States

Location

Phoenix Medical Group

Peoria, Arizona, 85381, United States

Location

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Pulmonary Associates of Burlingame

Burlingame, California, 94010, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505, United States

Location

Centura Health

Colorado Springs, Colorado, 80907, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

St. Mary's Hospital and Regional Medical

Grand Junction, Colorado, 81501, United States

Location

Starling Physicians

New Britain, Connecticut, 06051, United States

Location

Stamford Health

Stamford, Connecticut, 06904, United States

Location

Baycare

Clearwater, Florida, 33756, United States

Location

Oncology & Hematology Associates of West Broward

Coral Springs, Florida, 33065, United States

Location

Holy Cross Hospital Cancer Center

Fort Lauderdale, Florida, 33308, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Charter Research - The Villages

Orlando, Florida, 32803, United States

Location

Millennium Physicians Group, LLC

Port Charlotte, Florida, 33952, United States

Location

Charter Research - The Villages

The Villages, Florida, 32162, United States

Location

Pulmonary and Sleep Specialists of Northeast Georgia - Dacula

Dacula, Georgia, 30019, United States

Location

Christie Clinic

Champaign, Illinois, 61822, United States

Location

Duly Health and Care

Joliet, Illinois, 60435, United States

Location

Edward-Elmhurst Healthcare

Naperville, Illinois, 60540, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Louisville Pulmonary Care, PLLC

Louisville, Kentucky, 40207, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Gulfport

Gulfport, Mississippi, 39051, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Holy Name Pulmonary Associates

Englewood, New Jersey, 07631, United States

Location

Atlantic Digestive Health Institute

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Specialists

Mountain Lakes, New Jersey, 07046, United States

Location

MedCorps Asthma and Pulmonary Specialists - Sewell

Sewell, New Jersey, 08080, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

CHEAR Center LLC

The Bronx, New York, 10455, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Wilmington Health

Wilmington, North Carolina, 28401, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

Respiratory Specialists, Ltd.

Wyomissing, Pennsylvania, 19610, United States

Location

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

Location

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

Austin Regional Clinic ARC Clinical Research at Wilson Parke

Austin, Texas, 78726, United States

Location

Premier Family Physicians

Austin, Texas, 78735, United States

Location

Pulmonary Critical Care & Sleep Associates, P.A.

Conroe, Texas, 77304, United States

Location

Huntsville Research Institute, LLC

Huntsville, Texas, 77340, United States

Location

ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Pan American Center for Oncology Trials

San Juan, 00953, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 38829053 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Residual blood specimens may be used to develop and evaluate performance of biomarker assays to detect cancers or other conditions, laboratory process improvements, and proficiency testing. Residual blood specimens will be de-identified and will be stored for no more than 20 years.

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Mazzone, MD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Luke RG Pike, MD, DPhil

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (56)