Lung Cancer Clinical Trial
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
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).
Full 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.
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
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There are 68 Locations for this study
Cullman Alabama, 35055, United States
Mission Hills California, 91345, United States
Newport Beach California, 92663, United States
Redding California, 96001, United States
San Francisco California, 94121, United States
Walnut Creek California, 94598, United States
Grand Junction Colorado, 81501, United States
Wheat Ridge Colorado, 80033, United States
Stamford Connecticut, 06904, United States
Boynton Beach Florida, 33347, United States
Clearwater Florida, 33756, United States
Gainesville Florida, 32607, United States
Lehigh Acres Florida, 33936, United States
Ocala Florida, 34470, United States
Port Orange Florida, 32127, United States
Tampa Florida, 33607, United States
Acworth Georgia, 30101, United States
Columbus Georgia, 31904, United States
Columbus Georgia, 31904, United States
Hinesville Georgia, 31313, United States
Lawrenceville Georgia, 30046, United States
Rincon Georgia, 31326, United States
Peoria Illinois, 61637, United States
Springfield Illinois, 62703, United States
New Orleans Louisiana, 70121, United States
Biddeford Maine, 04005, United States
Baltimore Maryland, 21224, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Farmington Hills Michigan, 48336, United States
Minneapolis Minnesota, 55417, United States
Rochester Minnesota, 55905, United States
Hannibal Missouri, 63401, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Lincoln Nebraska, 68510, United States
Bridgeton New Jersey, 08302, United States
Santa Fe New Mexico, 87505, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27705, United States
Greenville North Carolina, 27834, United States
New Bern North Carolina, 28562, United States
Cincinnati Ohio, 45069, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73134, United States
Portland Oregon, 97202, United States
Portland Oregon, 97239, United States
DuBois Pennsylvania, 15801, United States
Lansdale Pennsylvania, 19446, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15217, United States
Pittsburgh Pennsylvania, 15224, United States
Charleston South Carolina, 28401, United States
Charleston South Carolina, 29407, United States
Myrtle Beach South Carolina, 29577, United States
Memphis Tennessee, 38120, United States
Houston Texas, 77008, United States
Houston Texas, 77070, United States
Huntsville Texas, 77340, United States
Irving Texas, 75038, United States
Katy Texas, 77494, United States
Kingwood Texas, 77339, United States
Richmond Virginia, 23249, United States
Renton Washington, 98055, United States
San Juan , 902, Puerto Rico
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