Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cases Series Subjects with confirmed lung cancer diagnosis |
Procedure: Blood collection
Peripheral blood will be collected via routine venipuncture procedure
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Screening Series Subjects undergoing LDCT for lung cancer screening |
Procedure: Blood collection
Peripheral blood will be collected via routine venipuncture procedure
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
- Positive Predictive Value [36 Months]
Performance of the assay in terms of PPV (positive predictive value)
Eligibility Criteria
Criteria
Inclusion Criteria - Cases:
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Current or past smokers, with at least 20 pack-years
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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:
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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
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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:
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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
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Subjects whose purpose of performing LDCT is for surveillance of a lung nodule
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | VA Connecticut Healthcare System | West Haven | Connecticut | United States | 06516 |
2 | Orlando Health, Inc. | Orlando | Florida | United States | 32806 |
3 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
4 | St. Elizabeth Edgewood Hospital | Edgewood | Kentucky | United States | 41017 |
5 | Norton Cancer Institute | Louisville | Kentucky | United States | 40202 |
6 | Johns Hopkins Medical Center | Baltimore | Maryland | United States | 21287 |
7 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
8 | Harry S. Truman Memorial Veterans' Hospital | Columbia | Missouri | United States | 65201 |
9 | Washington University in St. Louis | Saint Louis | Missouri | United States | 63110 |
10 | The University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
11 | Duke University | Durham | North Carolina | United States | 27705 |
12 | Durham VA Health Care System | Durham | North Carolina | United States | 27710 |
13 | Novant Health Cancer Research | Winston-Salem | North Carolina | United States | 27103 |
14 | Summa Health | Akron | Ohio | United States | 44304 |
15 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44106 |
16 | Ralph H. Johnson VA Medical Center | Charleston | South Carolina | United States | 29401 |
17 | Medical University of South Carolina (MUSC) | Charleston | South Carolina | United States | 29425 |
18 | Michael E. DeBakey VA Medical Center | Houston | Texas | United States | 77030 |
19 | Vancouver General Hospital/The University of British Columbia | Vancouver | British Columbia | Canada | V5Z 1M9 |
20 | University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- Nucleix Ltd.
Investigators
- Study Director: Aharona Shuali, MD, Nucleix Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
- Lung-RND-003