Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker

Study Overview
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Brief Summary
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Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.

Detailed Description
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In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.

Official Title
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Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer

Conditions
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High Risk of Developing Lung Cancer

Intervention / Treatment
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* Radiation: CT scan & Early CDT Lung test
* Other: CT scan & Early CDT Lung test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokers or former smokers At least 20 pack year history of smoking Ages 50 - 75 Exclusion Criteria: Had a CT scan of chest within last 24 months History of any cancer within 10 yrs (except skin cancer or cervical cancer) A serious illness that decreases life expectancy to less than 5 years Any current use of Oxygen Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CT scan & Early CDT Lung test<br>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<br> <br> * Other names: for lung cancer screening purposes;Other: CT scan & Early CDT Lung test<br> <br> * Other names: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT alone vs. both Early CDT-Lung test and CT scan. | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Early CDT-lung test in detecting cancer | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer screening, Smokers or former smokers, Family history of lung cancer