$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

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

2021-03-22

2025-07-15

2025-07-15

2992

Study Overview

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

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.

  • Lung Cancer
  • Head and Neck Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Kidney Cancer
  • Stomach Cancer
  • Colorectal Cancer
  • Pancreas Cancer
  • Liver Cancer
  • Skin Cancer
  • OTHER: Blood Sample Collection
  • DELFI-L101 Study

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-03-29  

N/A  

2025-08-05  

2021-03-30  

N/A  

2025-08-08  

2021-04-01  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis

OTHER: 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

OTHER: 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

OTHER: Blood Sample Collection

  • Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.Approximately 12 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Accuracy (sensitivity and specificity) in clinical subgroups of interestApproximately 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 collectionPoint in time of blood specimen collection (1day) at enrollment
Expected distribution of the DELFI score in the intended use population and clinical subgroups of interestApproximately 12 months
Association of genomic features with clinical subgroups of interestApproximately 12 months
Analytical performance (e.g. repeatability/reproducibility)Approximately 12 months
Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracyApproximately 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    All Participants:
    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: 5. 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 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:
    All Participants:
    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Peter Mazzone, MD, MPH, The Cleveland Clinic

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General 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.
    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate