CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)


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

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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Midthun, M.D.

Open for enrollment

Contact information:

Mitchell Strand

(507) 266-6705

More information


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