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Lung CancerDELFI-L201NCT05306288

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

An observational study of Lung Cancer, run by Delfi Diagnostics Inc. at 67 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Blood Sample Collection
How many people
11,935 participants
Where
67 sitesin 2 countries
Study dates
7 Apr 2022to 30 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • All subjects
  • Ability to understand and provide written informed consent
  • Age ≥ 50 years
  • Current or former smoker
  • ≥ 20 pack-years (pack years = number of packs per day × number of years smoked)
  • An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan)

Who cannot join

  • All subjects
  • 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
  • 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)
  • Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment
  • Any history of organ tissue transplantation
  • Any history of blood product transfusion within 120 days prior to enrollment
Show all 9Show fewer
  • Current pregnancy
  • Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
  • 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

Trial locations and contacts

67 sites in 2 countries.

67 sites in 2 countries

United States66 sites

  • American Clinical Trials, LLC.

    Acworth, Georgia, 30101

  • Johns Hopkins

    Baltimore, Maryland, 21224

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Advanced Research

    Boynton Beach, Florida, 33347

  • Internal Medicine Associate

    Bridgeton, New Jersey, 08302

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ralph H Johnson VA

    Charleston, South Carolina, 28401

  • Medical University of South Carolina

    Charleston, South Carolina, 29407

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45069

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Centricity Research Columbus Piedmont

    Columbus, Georgia, 31904

  • ClinCept, LLC

    Columbus, Georgia, 31904

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Science 37 (nationwide digital enrollment)

    Culver City, California, 90230

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Clinical Research Associates of Central Pa, LLC

    DuBois, Pennsylvania, 15801

  • Duke University

    Durham, North Carolina, 27705

  • Durham VA

    Durham, North Carolina, 27705

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan, 48336

  • SIMEDHealth, LLC

    Gainesville, Florida, 32607

  • SCL Health Research Institute, St. Mary's

    Grand Junction, Colorado, 81501

  • Hannibal Regional Healthcare System

    Hannibal, Missouri, 63401

  • Coastal Heritage Clinical Research

    Hinesville, Georgia, 31313

  • Greater Heights Memorial Pulmonary and Sleep

    Houston, Texas, 77008

  • Houston Pulmonary Sleep and Allergy Associates

    Houston, Texas, 77070

  • North Houston Cancer Clinics

    Huntsville, Texas, 77340

  • CHRISTUS Trinity Clinic Pulmonary Medicine

    Irving, Texas, 75038

  • R&H Clinical Research, Inc.

    Katy, Texas, 77494

  • Lumi Research

    Kingwood, Texas, 77339

  • Centricity Research Gwinnett Pulmonology

    Lawrenceville, Georgia, 30046

  • Galenus Group

    Lehigh Acres, Florida, 33936

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120

  • Minneapolis VA

    Minneapolis, Minnesota, 55417

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • LLM Research

    Myrtle Beach, South Carolina, 29577

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562

  • Ochsner

    New Orleans, Louisiana, 70121

  • Hoag Hospital

    Newport Beach, California, 92663

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Pittsburgh VA Healthcare System

    Pittsburgh, Pennsylvania, 15217

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

  • United Medical Research

    Port Orange, Florida, 32127

  • Northwest Research Center

    Portland, Oregon, 97202

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Paradigm Clinical Research Center, Inc.

    Redding, California, 96001

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055

  • Central Virginia VA Health System: Hunter Holmes McGuire

    Richmond, Virginia, 23249

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31326

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • San Francisco VA

    San Francisco, California, 94121

  • CHRISTUS St. Vincent Regional Medical Center

    Santa Fe, New Mexico, 87505

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Washington University

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stamford Health

    Stamford, Connecticut, 06904

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Clinical Research of California LLC

    Walnut Creek, California, 94598

  • Paradigm Clinical Research Center

    Wheat Ridge, Colorado, 80033

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials

    San Juan, 902

Other trials in Puerto Rico

About this study

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.

Read the 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.

Conditions
Lung Cancer
Being tested
Blood Sample Collection
Keywords
Lung Cancer Screening
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Sample CollectionOther

    Subjects enrolled in DELFI-L201 will have blood specimens collected (~30 mL) at enrollment or up to 30 days after enrollment.

Study groups in NCT05306288
Study groupRoleWhat they receive
Individuals with elevated-risk lung cancer (screening population)Not described
Receives: Other: Blood Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.

    Measured: Approximately 24 months

Secondary outcomes (2)

  1. Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.

    Measured: Up to approximately 36 months

  2. Adverse events (AEs) associated with the blood specimen collection.

    Measured: Point in time blood collection (1 day) at enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start7 Apr 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
11,935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306288
Sponsor's protocol ID
DELFI-L201
Acronym
DELFI-L201
Status last verified
Mar 2026
First submitted
23 Mar 2022
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Delfi Diagnostics Inc. at 67 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST. (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05306288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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