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

March 26, 2024 updated by: Delfi Diagnostics Inc.
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 902
        • Pan American Center for Oncology Trials
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
    • California
      • Culver City, California, United States, 90230
        • Science 37 (nationwide digital enrollment)
      • Mission Hills, California, United States, 91345
        • Providence Facey Medical Foundation
      • Newport Beach, California, United States, 92663
        • Hoag Hospital
      • Redding, California, United States, 96001
        • Paradigm Clinical Research Center, Inc.
      • San Francisco, California, United States, 94121
        • San Francisco VA
      • Walnut Creek, California, United States, 94598
        • Clinical Research of California LLC
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • SCL Health Research Institute, St. Mary's
      • Wheat Ridge, Colorado, United States, 80033
        • Paradigm Clinical Research Center
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Stamford Health
    • Florida
      • Boynton Beach, Florida, United States, 33347
        • Advanced Research
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Gainesville, Florida, United States, 32607
        • SIMEDHealth, LLC
      • Lehigh Acres, Florida, United States, 33936
        • Galenus Group
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research, LLC
      • Port Orange, Florida, United States, 32127
        • United Medical Research
      • Tampa, Florida, United States, 33607
        • Renew Health Clinical Research
    • Georgia
      • Acworth, Georgia, United States, 30101
        • American Clinical Trials, LLC.
      • Columbus, Georgia, United States, 31904
        • ClinCept, LLC
      • Columbus, Georgia, United States, 31904
        • Centricity Research Columbus Piedmont
      • Hinesville, Georgia, United States, 31313
        • Coastal Heritage Clinical Research
      • Lawrenceville, Georgia, United States, 30046
        • Centricity Research Gwinnett Pulmonology
      • Rincon, Georgia, United States, 31326
        • Centricity Research Rincon Pulmonology
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare
      • Morehead, Kentucky, United States, 40351
        • St. Clair Healthcare
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner
    • Maine
      • Biddeford, Maine, United States, 04005
        • MaineHealth Cancer Care - Biddeford
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Farmington Hills, Michigan, United States, 48336
        • Pulmonary Research Institute of Southeast Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Hannibal Regional Healthcare System
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • New Jersey
      • Bridgeton, New Jersey, United States, 08302
        • Internal Medicine Associate
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • CHRISTUS St. Vincent Regional Medical Center
    • New York
      • New Hyde Park, New York, United States, 11040
        • Northwell Health
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Durham, North Carolina, United States, 27705
        • Durham VA
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care, P.A.
    • Ohio
      • Cincinnati, Ohio, United States, 45069
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Hightower Clinical
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
      • Portland, Oregon, United States, 97202
        • Northwest Research Center
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central Pa, LLC
      • Lansdale, Pennsylvania, United States, 19446
        • Lung Health Services
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny Health Network
      • Pittsburgh, Pennsylvania, United States, 15217
        • Pittsburgh VA Healthcare System
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 28401
        • Ralph H Johnson VA
      • Myrtle Beach, South Carolina, United States, 29577
        • LLM Research
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Clinical Research Institute
    • Texas
      • Houston, Texas, United States, 77008
        • Greater Heights Memorial Pulmonary and Sleep
      • Houston, Texas, United States, 77070
        • Houston Pulmonary Sleep and Allergy Associates
      • Huntsville, Texas, United States, 77340
        • North Houston Cancer Clinics
      • Irving, Texas, United States, 75038
        • CHRISTUS Trinity Clinic Pulmonary Medicine
      • Katy, Texas, United States, 77494
        • R&H Clinical Research, Inc.
      • Kingwood, Texas, United States, 77339
        • Lumi Research
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Central Virginia VA Health System: Hunter Holmes McGuire
    • Washington
      • Renton, Washington, United States, 98055
        • UW Medicine Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
Time Frame: Approximately 4 months
Approximately 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Approximately 12 months
Adverse events (AEs) associated with the blood specimen collection.
Time Frame: Approximately 12 months
Approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delfi Diagnostics Inc.

Collaborators

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELFI-L201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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