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| ID | Type | Description | Link |
|---|---|---|---|
| State of Ohio grant | Other Grant/Funding Number | 06-055 | |
| 06-055 | Other Grant/Funding Number | State of Ohio |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all enrolled subjects | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chest x-ray with or without CAD, lose dose CT scan | Device | PA view, low dose CT scan |
|
| 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 |
| 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 |
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Inclusion Criteria:
ages 40-75 years
If ages 40-59, then one of the following criteria needs to be met:
If ages 60-75, then one of the following additional criteria needs to be met:
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:
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Primary care physicians or any other physician may refer potential candidates. Additionally, subjects may see marketing materials and contact the research team directly. There is no restriction to the area of residence of subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Micheal Phillips, M.D. | The Cleveland Clinic | Study Chair |
| Moulay Meziane, MD | Chair of Thoracic Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23952850 | Derived | Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC. | |
| 23527241 | Derived | Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D003936 | Diagnosis, Computer-Assisted |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for plasma and buffy coat retrieval
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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |