Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
Purpose
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
- Lung Cancer
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Exclusion Criteria - Screening: - 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cases Series | Subjects with confirmed lung cancer diagnosis |
|
| Screening Series | Subjects undergoing LDCT for lung cancer screening |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT04968548
- Status
- Recruiting
- Sponsor
- Nucleix Ltd.
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.