Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968548
• Other study ID #: Lung-RND-003
• Status: Recruiting
• Start date: September 17, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Nucleix Ltd.
• Contact: Rahda Duttagupta, PhD
• Phone: 8582833388
• Email: radha[@]nucleix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Blood collection
Peripheral blood will be collected via routine venipuncture procedure

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	McGill University Health Centre	Montréal	Quebec
Canada	University Health Network	Toronto	Ontario
Canada	Vancouver General Hospital/The University of British Columbia	Vancouver	British Columbia
United States	Summa Health	Akron	Ohio
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	The University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Harry S. Truman Memorial Veterans' Hospital	Columbia	Missouri
United States	Duke University	Durham	North Carolina
United States	Durham VA Health Care System	Durham	North Carolina
United States	St. Elizabeth Edgewood Hospital	Edgewood	Kentucky
United States	Scripps Memorial Hospital	Encinitas	California
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Centura Health	Lakewood	Colorado
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Baptist Cancer Center	Memphis	Tennessee
United States	University of Minnesota Health	Minneapolis	Minnesota
United States	Northwell Health	New Hyde Park	New York
United States	Orlando Health, Inc.	Orlando	Florida
United States	Owensboro Health	Owensboro	Kentucky
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	W.G. (Bill) Hefner VA Medical Center	Salisbury	North Carolina
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	VA Connecticut Healthcare System	West Haven	Connecticut
United States	Novant Health Cancer Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nucleix Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood samples	Collect blood to support the development and validation of a multi analyte test for lung cancer screening	24 Months
Primary	Clinical data collection	Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening	24 Months
Secondary	Performance	Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value)	36 Months
Secondary	Sensitivity	Performance of the assay in terms of Sensitivity	36 Months
Secondary	Specificity	Performance of the assay in terms of Specificity	36 Months
Secondary	Negative Predictive Value	Performance of the assay in terms of NPV (negative predictive value)	36 Months
Secondary	Positive Predictive Value	Performance of the assay in terms of PPV (positive predictive value)	36 Months