Transcript DECAMP flipchart 07-24-12x

Detection of Early Lung Cancer Among
Military Personnel
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
– 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
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
When
You
Join2the
Study
• Length
of study:
1/2 years
• 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.
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)
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
Study Flow Chart
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
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
• 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
Cost
ofwillParticipation
• You
receive no payment for taking part in this
study
• You will not be responsible for any costs associated
with the biospecimen collection
• 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
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
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
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
ForRegarding
Questions
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