Lung Cancer Clinical Trial
Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
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.
Full 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.
Eligibility Criteria
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
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There are 24 Locations for this study
West Haven Connecticut, 06516, United States
Orlando Florida, 32806, United States
Sarasota Florida, 34239, United States
Edgewood Kentucky, 41017, United States
Louisville Kentucky, 40202, United States
Owensboro Kentucky, 42303, United States
Baltimore Maryland, 21287, United States
Burlington Massachusetts, 01805, United States
Columbia Missouri, 65201, United States
Saint Louis Missouri, 63110, United States
Rochester New York, 14627, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Salisbury North Carolina, 28144, United States
Winston-Salem North Carolina, 27103, United States
Akron Ohio, 44304, United States
Cleveland Ohio, 44106, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Houston Texas, 77030, United States
Calgary Alberta, T2N 1, Canada
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G 2, Canada
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