CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-003100
NCT ID: NCT05306288
About this study
The purpose of this study is to determine the sensitivity and specificity of a blood test (DLCST) for the detection of lung cancer in a screening setting using the reference of Chest CT screening and a histologic diagnosis of lung cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 4/10/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available