Status:
ACTIVE_NOT_RECRUITING
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Lead Sponsor:
Delfi Diagnostics Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
50+ years
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 ...
Detailed Description
DELFI identifies circulating tumor DNA (ctDNA) to detect cancer. Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. The study purpose is to va...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
11935 Patients enrolled
Trial Details
Trial ID
NCT05306288
Start Date
April 7 2022
End Date
December 31 2026
Last Update
June 27 2025
Active Locations (67)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Science 37 (nationwide digital enrollment)
Culver City, California, United States, 90230
3
Providence Facey Medical Foundation
Mission Hills, California, United States, 91345
4
Hoag Hospital
Newport Beach, California, United States, 92663