Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01700257|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : December 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|High Risk of Developing Lung Cancer||Radiation: CT scan & Early CDT Lung test Other: CT scan & Early CDT Lung test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1361 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 7, 2020|
|Actual Study Completion Date :||December 7, 2020|
CT scan & Early CDT Lung test
Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.
Radiation: CT scan & Early CDT Lung test
Other: CT scan & Early CDT Lung test
Other Name: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
- CT alone vs. both Early CDT-Lung test and CT scan. [ Time Frame: One year ]Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
- Value of Early CDT-lung test in detecting cancer [ Time Frame: One year ]Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.
- Health Economics [ Time Frame: One Year ]Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700257
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||James R Jett, MD||National Jewish Health|