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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: Blood Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis<br> | Other: Blood Sample Collection<br>* Subjects enrolled in the DELFI-L101 will have blood specimens collected ( 40 mL) at enrollment.<br>|
| Individuals eligible for Lung Cancer screening with no cancer diagnosis<br> | Other: Blood Sample Collection<br>* Subjects enrolled in the DELFI-L101 will have blood specimens collected ( 40 mL) at enrollment.<br>|
| Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis<br> | Other: Blood Sample Collection<br>* Subjects enrolled in the DELFI-L101 will have blood specimens collected ( 40 mL) at enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC. |  | Approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (sensitivity and specificity) in clinical subgroups of interest |  | Approximately 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 collection |  | Point in time of blood specimen collection (1day) at enrollment | 
| Expected distribution of the DELFI score in the intended use population and clinical subgroups of interest |  | Approximately 12 months | 
| Association of genomic features with clinical subgroups of interest |  | Approximately 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) accuracy |  | Approximately 12 months |