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

NCT04968548 | Active Not Recruiting

• 1 other identifier: Lung-RND-003
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 31

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.

Conditions

Lung Cancer

Keywords

LDCT; Low Dose CT; Lung Cancer Screening; liquid biopsy; early detection; lung cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Performance

  36 Months

• Sensitivity

  36 Months

• Specificity

  36 Months

• Negative Predictive Value

  36 Months

• Positive Predictive Value

  36 Months

Study Arms (2)

Cases Series

Subjects with confirmed lung cancer diagnosis

Procedure: Blood collection

Screening Series

Subjects undergoing LDCT for lung cancer screening

Procedure: Blood collection

Interventions

Blood collection PROCEDURE

Peripheral blood will be collected via routine venipuncture procedure

Cases Series; Screening Series

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (31)

Scripps Memorial Hospital

Encinitas, California, 92024, United States

Location

Centura Health

Lakewood, Colorado, 80228, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Owensboro Health

Owensboro, Kentucky, 42303, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Minnesota Health

Minneapolis, Minnesota, 55455, United States

Location

Harry S. Truman Memorial Veterans' Hospital

Columbia, Missouri, 65201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Durham VA Health Care System

Durham, North Carolina, 27710, United States

Location

W.G. (Bill) Hefner VA Medical Center

Salisbury, North Carolina, 28144, United States

Location

Novant Health Cancer Research

Winston-Salem, North Carolina, 27103, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Vancouver General Hospital/The University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Related 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.

  PMID: 33122336 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Radha Duttagupta, PhD

  Nucleix Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 20, 2021
• Study Start: September 17, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); CA (4)