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NCT04825834 | RECRUITING | Lung Cancer

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

Delfi Diagnostics Inc.

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.

Condition or disease

Lung Cancer

Head and Neck Cancer

Esophageal Cancer

Bladder Cancer

Kidney Cancer

Stomach Cancer

Colorectal Cancer

Pancreas Cancer

Liver Cancer

Skin Cancer

Intervention/treatment

Blood Sample Collection

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2660 participants
Official Title : DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Actual Study Start Date : 2021-03-22
Estimated Primary Completion Date : 2025-05-31
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)

Location Details

NCT04825834

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195