Chest Imaging, Breath, and Biomarkers in a Screening Trial

Study Overview
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Brief Summary
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The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.

Detailed Description
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The fight against lung cancer is waged on three major fronts: prevention, detection and treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective. If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.

Official Title
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A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: chest x-ray with or without CAD, lose dose CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 40-75 years If ages 40-59, then one of the following criteria needs to be met: Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR current or ex-smoker with > 25 pack years and COPD OR current or ex-smoker with a > 35 pack year history If ages 60-75, then one of the following additional criteria needs to be met: Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR Current or ex-smoker with >25 pack years and COPD OR Current or ex-smoker with a >30 pack year history Subject is able to return to Cleveland Clinic for annual follow-up screening Subject is willing to sign a medical release form Exclusion Criteria: Current health requires oxygen Have had a chest x-ray or CT of the chest within the last 6 months Previous pneumonectomy Lobectomy of the lung within the last 5 years Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer A medical condition that would prevent treatment for lung cancer Within the last 6 weeks, one of the following has occured: A new cough or chronic cough that has gotten worse Either new shortness of breath, or any worsening of shortness of breath A cough producing blood Constant chest pain Respiratory infection, pneumonia, or cold Unintentional and unexplained weight loss greater than 5% of total body weight

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all enrolled subjects<br>Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples. | Device: chest x-ray with or without CAD, lose dose CT scan<br>* PA view, low dose CT scan<br>* Other names: computer aided detection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivities of chest x-ray with CAD and chest CT | The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period. | One year after scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific mortality between screening with chest x-ray and CAD versus no screening | Mortality rate in screening x-ray vs CAD | One year after scan | 
| All-cause mortality rate between screening with chest x-ray and CAD versus no screening | All cause mortality rate | One year after scan | 
| Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls | Time between randomization and symptom | One year after scan | 
| Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population | Cancer detection rate between chest x-ray and CAD | One year after scan | 
| The quality of life between screening with chest x-ray and CAD versus no screening. | Quality of life between the chest x-ray group and the CAD group | One year after scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, chest x-ray, CT scan, computer aided detection (CAD), screening, smokers