Lung Cancer
Conditions
Keywords
Lung Cancer Screening
Brief summary
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to demonstrate the performance characteristics, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DELFI Lung Cancer Screening Test (DLCST) for the detection of pathologically-confirmed lung cancer in a screening population using LDCT, pathology, and follow-up as the reference method.
Detailed description
DELFI identifies circulating fragments of DNA (cfDNA) and plasma biomarkers to detect cancer. Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. The study purpose is to validate the performance of the DELFI-based test for the detection of lung cancer among individuals eligible for routine lung cancer screening. Participants will have blood collected and medical record review at baseline and will have medical record reviews at additional timepoints.
Interventions
OTHERBlood Sample Collection
Subjects enrolled in DELFI-L201 will have blood specimens collected (\~30 mL) at enrollment or up to 30 days after enrollment.
Sponsors
Delfi Diagnostics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
* All subjects 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 × number of years smoked) 5. An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan)
Exclusion criteria
* All subjects 1. Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment 2. Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies) 3. Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment 4. Any history of organ tissue transplantation 5. Any history of blood product transfusion within 120 days prior to enrollment 6. Current pregnancy 7. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study 8. Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. | Approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. | Up to approximately 36 months |
| Adverse events (AEs) associated with the blood specimen collection. | Point in time blood collection (1 day) at enrollment |
Countries
Puerto Rico, United States
Outcome results
None listed