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

• ClinicalTrials.gov Identifier: NCT05306288
• Recruitment Status: Recruiting
• First Posted: April 1, 2022
• Last Update Posted: August 5, 2022
• Sponsor: Delfi Diagnostics Inc.
• Collaborator: 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: August 5, 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

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

Description:

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 23, 2022): 15000
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Amy Isaacson; (667) 400-0276; clindev@delfidiagnostics.com

Contact: Kaitlyn Drury; (667) 770-6597; clindev@delfidiagnostics.com

• Listed Location Countries: United States

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: February 2022