Clinical trial NCT04968548: Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
Official title: Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: LDCT
Low Dose CT
Lung Cancer Screening
liquid biopsy
early detection
lung cancer
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Case Series will include subjects 50-80 years old, current or past smokers with at least 20 pack-years, with either (a) a high suspicion for lung cancer, who are planning to undergo surgery to establish a definitive diagnosis; or (b) confirmed lung cancer diagnosis, however did not yet undergo any treatment for this cancerous lesion.

The Screening Series will include subjects 50-80 years old, current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening.

All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix

Brief summary: This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

Detailed description: This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.

Eligibility criteria: Inclusion Criteria - Cases:

* Current or past smokers, with at least 20 pack-years
* Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients

Exclusion Criteria - Cases:

* Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
* Current lung cancer is known to be stage III or IV by pathology.

Inclusion Criteria - Screening:

- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening

Exclusion Criteria - Screening:

* Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
* Subjects whose purpose of performing LDCT is for surveillance of a lung nodule

Primary outcomes:
measure: Collection of blood samples
timeFrame: 24 Months
measure: Clinical data collection
timeFrame: 24 Months
Secondary outcomes:
measure: Performance
timeFrame: 36 Months
measure: Sensitivity
timeFrame: 36 Months
measure: Specificity
timeFrame: 36 Months
measure: Negative Predictive Value
timeFrame: 36 Months
measure: Positive Predictive Value
timeFrame: 36 Months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Scripps Memorial Hospital
state: California
city: Lakewood
country: United States
facility: Centura Health
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Edgewood
country: United States
facility: St. Elizabeth Edgewood Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Health
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Health
state: Minnesota
city: Columbia
country: United States
facility: Harry S. Truman Memorial Veterans' Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Durham
country: United States
facility: Durham VA Health Care System
state: North Carolina
city: Salisbury
country: United States
facility: W.G. (Bill) Hefner VA Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Cancer Research
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital/The University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Nucleix Ltd.
name: Radha Duttagupta, PhD
role: STUDY_DIRECTOR
References:
citation: Gaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan.