DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis
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Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
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Individuals eligible for Lung Cancer screening with no cancer diagnosis
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Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
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Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis
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Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
|
Outcome Measures
Primary Outcome Measures
- Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC. [Approximately 12 months]
Secondary Outcome Measures
- Accuracy (sensitivity and specificity) in clinical subgroups of interest [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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
All Subjects:
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Ability to understand and provide written informed consent
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Age ≥ 50 years
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Current or Former Smoker
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≥ 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 (computed tomography (CT)) within 12 months of enrollment OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment
AND
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Meet one of the criteria below:
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No suspected or confirmed lung cancer diagnosis OR
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Suspected of lung cancer OR
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Confirmed, untreated lung cancer
Inclusion Group 2: High Risk Patients with cancer other than lung cancer that meet the following criteria:
- Pathologic confirmed, invasive cancer diagnosis, that is not lung cancer with no prior systemic therapy, definitive therapy, radiation, or surgical resection.
Exclusion Criteria:
All Subjects:
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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)
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Any history of hematologic malignancies or myelodysplasia
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Any history of organ tissue transplantation
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Any history of blood product transfusion
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Current pregnancy
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Any condition that in the opinion of the Investigator should preclude the subject's participation in the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
2 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Delfi Diagnostics Inc.
Investigators
- Principal Investigator: Peter Mazzone, MD, MPH, The Cleveland Clinic
- Principal Investigator: Luke RG Pike, MD, DPhil, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DELFI-L101 Study