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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,992
Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.
Central Alabama Research
Homewood, Alabama, United States
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
Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.
Time frame: Approximately 12 months
Accuracy (sensitivity and specificity) in clinical subgroups of interest
Time frame: Approximately 12 months
Prevalence-based measures, including positive predictive value (PPV), negative predictive value (NPV), and number needed to screen (NNS)
Time frame: Approximately 12 months
Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type)
Time frame: Approximately 12 months
Adverse events (AEs) associated with the blood specimen collection
Time frame: 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
Time frame: Approximately 12 months
Association of genomic features with clinical subgroups of interest
Time frame: Approximately 12 months
Analytical performance (e.g. repeatability/reproducibility)
Time frame: Approximately 12 months
Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy
Time frame: Approximately 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 47 more locations