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

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ClinicalTrials.gov Identifier: NCT05306288
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : September 14, 2022
Massachusetts General Hospital
Information provided by (Responsible Party):
Delfi Diagnostics Inc.

Tracking Information
First Submitted Date March 23, 2022
First Posted Date April 1, 2022
Last Update Posted Date September 14, 2022
Actual Study Start Date April 7, 2022
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2022)
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. [ Time Frame: Approximately 4 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 23, 2022)
  • Performance characteristics (sensitivity, specificity, PPV, NPV) of the Delfi DLCST based on results at the time of a 12-month follow-up. [ Time Frame: Approximately 12 months ]
  • Adverse events (AEs) associated with the blood specimen collection. [ Time Frame: Approximately 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Official Title CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Brief 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).
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Blood specimens will be de-identified and may be used to develop and evaluate performance of biomarker assays to detect cancers or other conditions, laboratory process improvements, and proficiency testing.
Sampling Method Non-Probability Sample
Study Population Participants will be men and women, current or former smokers, ≥ 50 years of age who are scheduled for a standard-of-care screening chest CT scan.
Condition Lung Cancer
Intervention Other: Blood Sample Collection
Subjects enrolled in DELFI-L201 will have blood specimens collected (~30 mL) at enrollment or up to 30 days from enrollment.
Study Groups/Cohorts Individuals with elevated-risk lung cancer (screening population)
Intervention: Other: Blood Sample Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 23, 2022)
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 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
    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 malignancies or myelodysplasia
    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
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contact: Amy Isaacson (667) 400-0276 clindev@delfidiagnostics.com
Contact: Kaitlyn Drury (667) 770-6597 clindev@delfidiagnostics.com
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT05306288
Other Study ID Numbers DELFI-L201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Individual participant data that underlie the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, and informed consent form may also be shared. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Current Responsible Party Delfi Diagnostics Inc.
Original Responsible Party Same as current
Current Study Sponsor Delfi Diagnostics Inc.
Original Study Sponsor Same as current
Collaborators Massachusetts General Hospital
Investigators Not Provided
PRS Account Delfi Diagnostics Inc.
Verification Date September 2022