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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Blood collection

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital/The University of British Columbia
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • McGill University Health Centre
• United States
  • California
    • Encinitas, California, United States, 92024
      • Scripps Memorial Hospital
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Centura Health
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Edgewood Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Health
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Health
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Harry S. Truman Memorial Veterans' Hospital
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
    • Rochester, New York, United States, 14627
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Durham, North Carolina, United States, 27710
      • Durham VA Health Care System
    • Salisbury, North Carolina, United States, 28144
      • W.G. (Bill) Hefner VA Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Cancer Research
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VA Medical Center
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases Series; Subjects with confirmed lung cancer diagnosis	Procedure: Blood collection; Peripheral blood will be collected via routine venipuncture procedure
Screening Series; Subjects undergoing LDCT for lung cancer screening	Procedure: Blood collection; Peripheral blood will be collected via routine venipuncture procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of blood samples	Collect blood to support the development and validation of a multi analyte test for lung cancer screening	24 Months
Clinical data collection	Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sensitivity	Performance of the assay in terms of Sensitivity	36 Months
Specificity	Performance of the assay in terms of Specificity	36 Months
Negative Predictive Value	Performance of the assay in terms of NPV (negative predictive value)	36 Months
Positive Predictive Value	Performance of the assay in terms of PPV (positive predictive value)	36 Months

Collaborators and Investigators

• Sponsor: Nucleix Ltd.
• Investigators: Study Director: Radha Duttagupta, PhD, Nucleix Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: early detection; lung cancer; liquid biopsy; LDCT; Low Dose CT; Lung Cancer Screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: Lung-RND-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No