Bladder Cancer, Colorectal Cancer, Esophageal Cancer, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Pancreas Cancer, Skin Cancer, Stomach Cancer
Conditions
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.
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.
Interventions
OTHERBlood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\ 40 mL) at enrollment.
Sponsors
Delfi Diagnostics Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC. | Approximately 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Adverse events (AEs) associated with the blood specimen collection | Point in time of blood specimen collection (1day) at enrollment |
| 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 |
| Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy | Approximately 12 months |
| Accuracy (sensitivity and specificity) in clinical subgroups of interest | Approximately 12 months |
Countries
Puerto Rico, United States
Outcome results
None listed