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

March 17, 2026 updated by: Delfi Diagnostics Inc.
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to demonstrate the performance characteristics, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DELFI Lung Cancer Screening Test (DLCST) for the detection of pathologically-confirmed lung cancer in a screening population using LDCT, pathology, and follow-up as the reference method.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

DELFI identifies circulating fragments of DNA (cfDNA) and plasma biomarkers to detect cancer. Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. 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 record reviews at additional timepoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11935

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Port Orange, Florida, United States, 32127
        • United Medical 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
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner
    • 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
      • St Louis, Missouri, United States, 63110
        • Washington University
      • St 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
      • 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
      • 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
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 after enrollment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
Time Frame: Approximately 24 months
Approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Adverse events (AEs) associated with the blood specimen collection.
Time Frame: Point in time blood collection (1 day) at enrollment
Point in time blood collection (1 day) at enrollment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Delfi Diagnostics Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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