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

Launched by DELFI DIAGNOSTICS INC. · Mar 30, 2021

Keywords

ClinConnect Summary

The DELFI-L101 Study is a clinical trial aimed at improving the early detection of lung cancer by testing a special method called the DELFI assay. The goal is to train and evaluate tools that can help identify lung cancer using DNA fragments and other health information. The trial is currently looking for participants, specifically adults aged 50 and older who are current or former smokers with a history of smoking at least 20 pack-years (which means smoking a pack a day for 20 years, or similar). Participants may have no lung cancer diagnosis, be suspected of having lung cancer, or have confirmed but untreated lung cancer. Additionally, individuals with certain types of non-lung cancers who meet specific criteria may also be eligible.

If you decide to participate, you will contribute to important research that aims to catch lung cancer earlier, which could lead to better treatment outcomes. Participants will need to provide informed consent, meaning they understand what the study involves, and they must meet certain health criteria. It's also important to note that those with recent cancer treatments or specific health conditions may not be eligible to join. Overall, this trial represents an exciting opportunity to help advance cancer detection methods for a wide range of cancers.

Gender

ALL

Eligibility 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