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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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)
  • 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
  • 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.
  • 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Delfi Diagnostics Inc.,

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

Luke RG Pike, MD, DPhil, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-05-31