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D etection of E arly Lung C ancer A mong M ilitary P ersonnel Study 1

D etection of E arly Lung C ancer A mong M ilitary P ersonnel Study 1 . Version 04-04-12. Purpose of the Study. Military relevance Lung cancer is the leading cause of death from cancer in the United States and the world, with cigarette smoking as its major cause

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D etection of E arly Lung C ancer A mong M ilitary P ersonnel Study 1

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  1. Detection of Early Lung Cancer Among Military Personnel Study 1 Version 04-04-12

  2. Purpose of the Study • Military relevance • Lung cancer is the leading cause of death from cancer in the United States and the world, with cigarette smoking as its major cause • Military personnel have higher rates of smoking than the general population, as well as exposure to other carcinogens, and there is a significantly higher incidence of lung cancer among military veterans

  3. Purpose of the Study (cont’d) • Clinical Trial Goals • To improve the evaluation of patients with indeterminate pulmonary nodules • To evaluate the ability of different types of tests to predict if the nodule seen on your imaging scan will become malignant (cancerous) or benign (noncancerous) • Total number of study participants: 500

  4. When You Join the Study • Length of study: 2 1/2years • You will be asked to: • Complete a lung questionnaire, a bronchoscopy, and a lung function test • Provide different types of biological samples (urine, blood, sputum, cells, and tissue) • Return for a follow-up visits to check on your nodule by clinical examinations, diagnostic work-ups, and imaging scans • Undergo surgery, if necessary and prescribed. Surgery is not part of the study. • A biopsy sample will be obtained.

  5. Diagnosis What is an “indeterminate pulmonary nodule”? • Small, roundish growth often occurring in the lungs from scarring, inflammation, or infection • Can be benign (noncancerous) or malignant (cancerous)

  6. Treatment You will receive standard-of-care clinical examinations, work-up, and imaging scans to follow your condition The result of these different tests will be compared with your final diagnosis This information will be used in the future to predict the outcome of similar nodules in other patients

  7. Study Flow Chart

  8. Risks Associated with Participation You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. Talk to your doctor or nurse about any side effects that you have while taking part in the study

  9. Benefits of Participation • Taking part in this study may or may not make your health better. The information from this study will help doctors: • Better understand these indeterminate pulmonary nodules • Use these results to distinguish malignant (cancerous) nodules from benign (noncancerous) nodules in the future

  10. We will do our best to make sure that your personal information will be kept private • All personal information will be removed and replaced with a unique identifying number to protect your identity

  11. Cost of Participation • You will receive no payment for taking part in this study • You will not be responsible for any costs associated with the biospecimencollection • Taking part in this study should not lead to any added costs to you or your insurance company • You and/or your health insurance will be charged for any portion of your care that is considered standard of care, such as visits to follow up your nodule

  12. Cost of Participation (cont’d) • You may be responsible for any copayments and deductibles that are standard for your insurance coverage • You and/or your insurance company will be charged for continuing medical care and/or hospitalization, including emergency medical care

  13. In Case of Injury If you are injured while on the study, it is important that you tell your study doctor In the case of medical emergency, injury, or illness during this study, emergency medical treatment is available but will be provided at the usual charge. You and/or your insurance will be responsible for the cost of the medical care of that illness or injury

  14. Your Rights • Taking part in this study is your choice • You may choose not to take part in the study • If you decide to participate, you are free to leave the study at any time • No matter what decision you make, there will be no penalty to you, and you will not lose any of your regular treatment and medical care options now or in the future. You can still get your medical care from our institution

  15. For Questions Regarding patients’ rights: • Ask your study doctor or research associate who you should contact at the institutional review board (IRB) For more information about the study and other helpful resources please visit our Web site: www.decamp.com

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