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History of Changes for Study: NCT05306288
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)
Latest version (submitted September 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 23, 2022 None (earliest Version on record)
2 June 9, 2022 Recruitment Status, Study Status and Contacts/Locations
3 June 17, 2022 Contacts/Locations and Study Status
4 July 13, 2022 Contacts/Locations and Study Status
5 July 13, 2022 Contacts/Locations and Study Status
6 July 21, 2022 Contacts/Locations and Study Status
7 July 22, 2022 Contacts/Locations and Study Status
8 July 28, 2022 Contacts/Locations and Study Status
9 August 2, 2022 Contacts/Locations and Study Status
10 August 4, 2022 Contacts/Locations and Study Status
11 August 25, 2022 Contacts/Locations and Study Status
12 September 12, 2022 Study Status and Contacts/Locations
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Study NCT05306288
Submitted Date:  March 23, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: DELFI-L201
Brief Title: CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)
Official Title: CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2022
Overall Status: Not yet recruiting
Study Start: March 31, 2022
Primary Completion: March 31, 2025 [Anticipated]
Study Completion: March 31, 2025 [Anticipated]
First Submitted: March 23, 2022
First Submitted that
Met QC Criteria:
March 23, 2022
First Posted: April 1, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
March 23, 2022
Last Update Posted: April 1, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Delfi Diagnostics Inc.
Responsible Party: Sponsor
Collaborators: Massachusetts General Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Lung Cancer
Keywords: Lung Cancer Screening
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen 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.
Enrollment: 15000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Individuals with elevated-risk lung cancer (screening population)
Blood Sample Collection
Subjects enrolled in DELFI-L201 will have blood specimens collected (~30 mL) at enrollment or up to 30 days from enrollment.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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
Open or close this module Contacts/Locations
Central Contact Person: Amy Isaacson
Telephone: 8186052218
Email: isaacson@delfidiagnostics.com
Central Contact Backup: Kaitlyn Drury
Telephone: 2482551824
Email: drury@delfidiagnostics.com
Locations: United States, North Carolina
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, United States, 28562
Contact:Contact: Amy Isaacson
Open or close this module IPDSharing
Plan to Share IPD: Undecided
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.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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