Lung Cancer
Conditions
Keywords
LDCT, Low Dose CT, Lung Cancer Screening, liquid biopsy, early detection, lung cancer
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.
Interventions
PROCEDUREBlood collection
Peripheral blood will be collected via routine venipuncture procedure
Sponsors
Nucleix Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Inclusion criteria
- Cases: * 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
Exclusion criteria
- Cases: * 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. Inclusion Criteria - Screening: \- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 36 Months | Performance of the assay in terms of Specificity |
| 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) |
| Positive Predictive Value | 36 Months | Performance of the assay in terms of PPV (positive predictive value) |
| Negative Predictive Value | 36 Months | Performance of the assay in terms of NPV (negative predictive value) |
| Sensitivity | 36 Months | Performance of the assay in terms of Sensitivity |
Countries
Canada, United States
Outcome results
None listed