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

Lung Cancer Clinical Trial

— DELFI-L201  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05306288
• Other study ID #: DELFI-L201
• Status: Active, not recruiting
• Start date: April 7, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Delfi Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Delfi Diagnostics Inc.	Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.		Approximately 4 months
Secondary	Performance characteristics (sensitivity, specificity, PPV, NPV) of the Delfi DLCST based on results at the time of a 12-month follow-up.		Approximately 12 months
Secondary	Adverse events (AEs) associated with the blood specimen collection.		Approximately 12 months