Clinical trial NCT05306288: CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Official title: CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: Lung Cancer Screening
Lead sponsor: Delfi Diagnostics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2022-04-01
Enrollment: 15000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
timeFrame: Approximately 4 months
Secondary outcomes:
measure: Performance characteristics (sensitivity, specificity, PPV, NPV) of the Delfi DLCST based on results at the time of a 12-month follow-up.
timeFrame: Approximately 12 months
measure: Adverse events (AEs) associated with the blood specimen collection.
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Culver City
country: United States
facility: Science 37 (nationwide digital enrollment)
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Center, Inc.
state: California
city: San Francisco
country: United States
facility: San Francisco VA
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California LLC
state: California
city: Grand Junction
country: United States
facility: SCL Health Research Institute, St. Mary's
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Center
state: Colorado
city: Stamford
country: United States
facility: Stamford Health
state: Connecticut
city: Boynton Beach
country: United States
facility: Advanced Research
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC
state: Florida
city: Lehigh Acres
country: United States
facility: Galenus Group
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: Tampa
country: United States
facility: Renew Health Clinical Research
state: Florida
city: Acworth
country: United States
facility: American Clinical Trials, LLC.
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Piedmont
state: Georgia
city: Columbus
country: United States
facility: ClinCept, LLC
state: Georgia
city: Hinesville
country: United States
facility: Coastal Heritage Clinical Research
state: Georgia
city: Lawrenceville
country: United States
facility: Centricity Research Gwinnett Pulmonology
state: Georgia
city: Rincon
country: United States
facility: Centricity Research Rincon Pulmonology
state: Georgia
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Morehead
country: United States
facility: St. Clair Healthcare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
city: Biddeford
country: United States
facility: MaineHealth Cancer Care - Biddeford
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Pulmonary Research Institute of Southeast Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Bridgeton
country: United States
facility: Internal Medicine Associate
state: New Jersey
city: Santa Fe
country: United States
facility: CHRISTUS St. Vincent Regional Medical Center
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Durham
country: United States
facility: Durham VA
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A.
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central Pa, LLC
state: Pennsylvania
city: Lansdale
country: United States
facility: Lung Health Services
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh VA Healthcare System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H Johnson VA
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: LLM Research
state: South Carolina
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Greater Heights Memorial Pulmonary and Sleep
state: Texas
city: Houston
country: United States
facility: Houston Pulmonary Sleep and Allergy Associates
state: Texas
city: Huntsville
country: United States
facility: North Houston Cancer Clinics
state: Texas
city: Irving
country: United States
facility: CHRISTUS Trinity Clinic Pulmonary Medicine
state: Texas
city: Katy
country: United States
facility: R&H Clinical Research, Inc.
state: Texas
city: Kingwood
country: United States
facility: Lumi Research
state: Texas
city: Richmond
country: United States
facility: Central Virginia VA Health System: Hunter Holmes McGuire
state: Virginia
city: Renton
country: United States
facility: UW Medicine Valley Medical Center
state: Washington
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials
Study officials:
References: