IRB Study Number 22-817
Status Recruiting
Phase Not Applicable
Location A Building - Crile Building
Institute Respiratory Institute
Description
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).
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 cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ (transitional cell carcinoma in situ and bladder carcinoma in situ are exclusionary) 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 malignancies or myelodysplasia
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
