Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
- Conditions
- Lung Cancer
- Interventions
- Procedure: Blood collection
- Registration Number
- NCT04968548
- Lead Sponsor
- Nucleix Ltd.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases Series Blood collection Subjects with confirmed lung cancer diagnosis Screening Series Blood collection Subjects undergoing LDCT for lung cancer screening
- Primary Outcome Measures
Name Time Method Collection of blood samples 24 Months Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Clinical data collection 24 Months Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening
- Secondary Outcome Measures
Name Time Method Specificity 36 Months Performance of the assay in terms of Specificity
Negative Predictive Value 36 Months Performance of the assay in terms of NPV (negative predictive value)
Performance 36 Months Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value)
Sensitivity 36 Months Performance of the assay in terms of Sensitivity
Positive Predictive Value 36 Months Performance of the assay in terms of PPV (positive predictive value)
Trial Locations
- Locations (31)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Durham VA Health Care System
🇺🇸Durham, North Carolina, United States
Scripps Memorial Hospital
🇺🇸Encinitas, California, United States
St. Elizabeth Edgewood Hospital
🇺🇸Edgewood, Kentucky, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Harry S. Truman Memorial Veterans' Hospital
🇺🇸Columbia, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Minnesota Health
🇺🇸Minneapolis, Minnesota, United States
VA Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States
Owensboro Health
🇺🇸Owensboro, Kentucky, United States
Centura Health
🇺🇸Lakewood, Colorado, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Vancouver General Hospital/The University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
W.G. (Bill) Hefner VA Medical Center
🇺🇸Salisbury, North Carolina, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Summa Health
🇺🇸Akron, Ohio, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Novant Health Cancer Research
🇺🇸Winston-Salem, North Carolina, United States
Ralph H. Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States
The University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States