Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
NCT ID: NCT04968548
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
5000 participants
OBSERVATIONAL
2021-09-17
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases Series
Subjects with confirmed lung cancer diagnosis
Blood collection
Peripheral blood will be collected via routine venipuncture procedure
Screening Series
Subjects undergoing LDCT for lung cancer screening
Blood collection
Peripheral blood will be collected via routine venipuncture procedure
Interventions
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Blood collection
Peripheral blood will be collected via routine venipuncture procedure
Eligibility Criteria
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Inclusion Criteria
* 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
\- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening
Exclusion Criteria
* Current lung cancer is known to be stage III or IV by pathology.
* 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
50 Years
80 Years
ALL
No
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Radha Duttagupta, PhD
Role: STUDY_DIRECTOR
Nucleix Ltd.
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Northwell Health
New Hyde Park, New York, United States
University of Rochester
Rochester, New York, United States
The University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Durham VA Health Care System
Durham, North Carolina, United States
W.G. (Bill) Hefner VA Medical Center
Salisbury, North Carolina, United States
Novant Health Cancer Research
Winston-Salem, North Carolina, United States
Summa Health
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
University of Calgary
Calgary, Alberta, Canada
Vancouver General Hospital/The University of British Columbia
Vancouver, British Columbia, Canada
University Health Network
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Scripps Memorial Hospital
Encinitas, California, United States
Centura Health
Lakewood, Colorado, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Orlando Health, Inc.
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Owensboro Health
Owensboro, Kentucky, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Minnesota Health
Minneapolis, Minnesota, United States
Harry S. Truman Memorial Veterans' Hospital
Columbia, Missouri, United States
Countries
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References
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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.
Other Identifiers
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Lung-RND-003
Identifier Type: -
Identifier Source: org_study_id
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