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

Completed

Conditions studied: Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Bladder Cancer, Kidney Cancer, Stomach Cancer, Colorectal Cancer, Pancreas Cancer, Liver Cancer, Skin Cancer

In brief

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.

Key facts

Study ID

NCT04825834

Run by

Delfi Diagnostics Inc.

People needed

2992

Starts

2021-03-22

Expected to finish

2025-07-15

Last updated by the study team

2025-08-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
• 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.

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
• 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

Where it is running

• Phoenix Medical Group — Peoria, Arizona, United States
• Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas, United States
• Pulmonary Associates of Burlingame — Burlingame, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States
• Centura Health — Colorado Springs, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• St. Mary's Hospital and Regional Medical — Grand Junction, Colorado, United States
• Starling Physicians — New Britain, Connecticut, United States
• Stamford Health — Stamford, Connecticut, United States
• Baycare — Clearwater, Florida, United States
• Oncology & Hematology Associates of West Broward — Coral Springs, Florida, United States
• Holy Cross Hospital Cancer Center — Fort Lauderdale, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Charter Research - The Villages — Orlando, Florida, United States
• Millennium Physicians Group, LLC — Port Charlotte, Florida, United States
• Charter Research - The Villages — The Villages, Florida, United States
• Pulmonary and Sleep Specialists of Northeast Georgia - Dacula — Dacula, Georgia, United States
• Christie Clinic — Champaign, Illinois, United States
• Duly Health and Care — Joliet, Illinois, United States
• Edward-Elmhurst Healthcare — Naperville, Illinois, United States
• The Iowa Clinic — West Des Moines, Iowa, United States
• Hutchinson Clinic — Hutchinson, Kansas, United States
• Louisville Pulmonary Care, PLLC — Louisville, Kentucky, United States
• Central Alabama Research — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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