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Lung CancerDELFI-L101NCT04825834

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

An observational study of Lung Cancer and Head and Neck Cancer, run by Delfi Diagnostics Inc. at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Blood Sample Collection
How many people
2,992 participants
Where
57 sitesin 2 countries
Study dates
22 Mar 2021to 15 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
  • Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
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  • Prior thoracic imaging with computed tomography (CT) within 12 months of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)
  • OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)
  • AND
  • Meet one of the criteria below:
  • No suspected or confirmed lung cancer diagnosis OR
  • Suspected of lung cancer OR
  • Confirmed, untreated lung cancer
  • Inclusion Group 2: High Risk Patients that meet the following criteria:
  • 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.

Who cannot join

  • 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
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  • Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
  • 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)
  • Enrollment in any DELFI sponsored study

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States56 sites

  • Austin Regional Clinic ARC Clinical Research at Wilson Parke

    Austin, Texas, 78726

  • Premier Family Physicians

    Austin, Texas, 78735

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Pulmonary Associates of Burlingame

    Burlingame, California, 94010

  • Christie Clinic

    Champaign, Illinois, 61822

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Baycare

    Clearwater, Florida, 33756

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Centura Health

    Colorado Springs, Colorado, 80907

  • Pulmonary Critical Care & Sleep Associates, P.A.

    Conroe, Texas, 77304

  • Oncology & Hematology Associates of West Broward

    Coral Springs, Florida, 33065

  • Pulmonary and Sleep Specialists of Northeast Georgia - Dacula

    Dacula, Georgia, 30019

  • National Jewish Health

    Denver, Colorado, 80206

  • Holy Name Pulmonary Associates

    Englewood, New Jersey, 07631

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

  • Holy Cross Hospital Cancer Center

    Fort Lauderdale, Florida, 33308

  • St. Mary's Hospital and Regional Medical

    Grand Junction, Colorado, 81501

  • East Carolina University

    Greenville, North Carolina, 27834

  • Memorial Gulfport

    Gulfport, Mississippi, 39051

  • Central Alabama Research

    Homewood, Alabama, 35209

  • Huntsville Research Institute, LLC

    Huntsville, Texas, 77340

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Duly Health and Care

    Joliet, Illinois, 60435

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Louisville Pulmonary Care, PLLC

    Louisville, Kentucky, 40207

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Atlantic Digestive Health Institute

    Morristown, New Jersey, 07960

  • Oncology Hematology Specialists

    Mountain Lakes, New Jersey, 07046

  • Edward-Elmhurst Healthcare

    Naperville, Illinois, 60540

  • Starling Physicians

    New Britain, Connecticut, 06051

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Northwell Health

    New York, New York, 10075

  • Charter Research - The Villages

    Orlando, Florida, 32803

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

  • Millennium Physicians Group, LLC

    Port Charlotte, Florida, 33952

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • MedCorps Asthma and Pulmonary Specialists - Sewell

    Sewell, New Jersey, 08080

  • Washington University at St. Louis

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stamford Health

    Stamford, Connecticut, 06904

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • CHEAR Center LLC

    The Bronx, New York, 10455

  • Charter Research - The Villages

    The Villages, Florida, 32162

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • ProHealth Care

    Waukesha, Wisconsin, 53188

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

  • Wilmington Health

    Wilmington, North Carolina, 28401

  • Respiratory Specialists, Ltd.

    Wyomissing, Pennsylvania, 19610

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials

    San Juan, 00953

Other trials in Puerto Rico

About this study

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.

Read the detailed description

Subjects will be enrolled into the DELFI-L101 study after informed consent and eligibility is confirmed. At enrollment, subjects will have blood specimens collected (~40 mL) and 12 months post-enrollment their medical records will be reviewed.

Being tested
Blood Sample Collection
Medical subject headings
Lung Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Sample CollectionOther

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

Study groups in NCT04825834
Study groupRoleWhat they receive
Individuals eligible for Lung Cancer screening with Lung Cancer diagnosisNot described
Receives: Other: Blood Sample Collection
Individuals eligible for Lung Cancer screening with no cancer diagnosisNot described
Receives: Other: Blood Sample Collection
Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosisNot described
Receives: Other: Blood Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 12 months

Secondary outcomes (8)

  1. Accuracy (sensitivity and specificity) in clinical subgroups of interest

    Measured: Approximately 12 months

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

    Measured: Approximately 12 months

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

    Measured: Approximately 12 months

  4. Adverse events (AEs) associated with the blood specimen collection

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

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

    Measured: Approximately 12 months

  6. Association of genomic features with clinical subgroups of interest

    Measured: Approximately 12 months

  7. Analytical performance (e.g. repeatability/reproducibility)

    Measured: Approximately 12 months

  8. Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start22 Mar 2021
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04825834
Sponsor's protocol ID
DELFI-L101 Study
Acronym
DELFI-L101
Status last verified
Aug 2025
First submitted
29 Mar 2021
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38829053

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Head and Neck Cancer, run by Delfi Diagnostics Inc. at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC. (time frame: Approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04825834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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