NCT04968548Completed
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6182 (actual)
- First submitted
- 4 Jul 2021
- Start date
- 17 Sept 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Nucleix Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT04968548
What you commit to
- Study type: Observational
- Participants enrolled: 6182
- From 17 Sept 2021 to the primary completion date, 31 Dec 2025
- 31 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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
Other
- Subjects whose purpose of performing LDCT is for surveillance of a lung nodule
Who the study is looking for
- 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
- \- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening
Age in the registry: 50 years to 80 years · Sex: All
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver General Hospital/The University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Summa Health Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Johns Hopkins Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Lahey Hospital and Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| The University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Ralph H. Johnson VA Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Harry S. Truman Memorial Veterans' Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Durham VA Health Care System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| St. Elizabeth Edgewood Hospital Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| Scripps Memorial Hospital Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
| Michael E. DeBakey VA Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Centura Health Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Baptist Cancer Center Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of Minnesota Health Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Orlando Health, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Owensboro Health Coordinator of this site? Confirm its status | Owensboro | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| W.G. (Bill) Hefner VA Medical Center Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| Sarasota Memorial Hospital Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| VA Connecticut Healthcare System Coordinator of this site? Confirm its status | West Haven | United States | Unknown status |
| Novant Health Cancer Research Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.