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

November 1, 2025 updated by: Nucleix Ltd.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 Months
Collect blood to support the development and validation of a multi analyte test for lung cancer screening
24 Months
Clinical data collection
Time Frame: 24 Months
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
Time Frame: 36 Months
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
Time Frame: 36 Months
Performance of the assay in terms of Sensitivity
36 Months
Specificity
Time Frame: 36 Months
Performance of the assay in terms of Specificity
36 Months
Negative Predictive Value
Time Frame: 36 Months
Performance of the assay in terms of NPV (negative predictive value)
36 Months
Positive Predictive Value
Time Frame: 36 Months
Performance of the assay in terms of PPV (positive predictive value)
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucleix Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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