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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05306288
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : June 2, 2023
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Delfi Diagnostics Inc.

Study Description
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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).

Condition or disease Intervention/treatment
Lung Cancer Other: Blood Sample Collection

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 Design
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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Individuals with elevated-risk lung cancer (screening population) 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.


Outcome Measures
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Primary Outcome Measures :
  1. Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. [ Time Frame: Approximately 4 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Adverse events (AEs) associated with the blood specimen collection. [ Time Frame: Approximately 12 months ]

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.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05306288


Contacts
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Contact: Amy Isaacson (667) 400-0276 clindev@delfidiagnostics.com
Contact: Kaitlyn Drury (667) 770-6597 clindev@delfidiagnostics.com

Locations
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Sponsors and Collaborators
Delfi Diagnostics Inc.
Massachusetts General Hospital
More Information
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Responsible Party: Delfi Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT05306288    
Other Study ID Numbers: DELFI-L201
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: January 2023
Individual Participant Data (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.

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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
Keywords provided by Delfi Diagnostics Inc.:
Lung Cancer Screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases