CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung

Study Overview
=================
Brief Summary
-----------------
CASCADE-LUNG is an event-driven, multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to determine the sensitivity and specificity of the Delfi Lung Cancer ScreeningTest (DLCST).

Detailed Description
-----------------
Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. DELFI identifies circulating tumor DNA (ctDNA) to detect cancer. 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 records reviews at two additional timepoints.

Official Title
-----------------
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Blood Sample Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects Ability to understand and provide written informed consent Age ≥ 50 years Current or former smoker ≥ 20 pack-years (pack years = number of packs per day × number of years smoked) 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 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 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) Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment Any history of organ tissue transplantation Any history of blood product transfusion within 120 days prior to enrollment Current pregnancy Any condition that in the opinion of the Investigator should preclude the participant's participation in the study 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with elevated-risk lung cancer (screening population)<br> | Other: Blood Sample Collection<br>* Subjects enrolled in DELFI-L201 will have blood specimens collected ( 30 mL) at enrollment or up to 30 days from enrollment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. |  | Approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance characteristics (sensitivity, specificity, PPV, NPV) of the Delfi DLCST based on results at the time of a 12-month follow-up. |  | Approximately 12 months | 
| Adverse events (AEs) associated with the blood specimen collection. |  | Approximately 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer Screening