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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Other: Blood Sample Collection. Subjects enrolled in the DELFI-L101 will have blood specimens collected (\~40 mL) at enrollment.

Arm public domain (ClinicalTrials.gov)

Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis ():

Arm public domain (ClinicalTrials.gov)

Individuals eligible for Lung Cancer screening with no cancer diagnosis ():

Arm public domain (ClinicalTrials.gov)

Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis ():

Primary outcome public domain (ClinicalTrials.gov)

Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.. Time frame: Approximately 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Accuracy (sensitivity and specificity) in clinical subgroups of interest. Time frame: Approximately 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Prevalence-based measures, including positive predictive value (PPV), negative predictive value (NPV), and number needed to screen (NNS). Time frame: Approximately 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type). Time frame: Approximately 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Adverse events (AEs) associated with the blood specimen collection. Time frame: Point in time of blood specimen collection (1day) at enrollment.

Secondary outcome public domain (ClinicalTrials.gov)

Expected distribution of the DELFI score in the intended use population and clinical subgroups of interest. Time frame: Approximately 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Association of genomic features with clinical subgroups of interest. Time frame: Approximately 12 months.

Eligibility public domain (ClinicalTrials.gov)

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 …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 2992 participants (actual).