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Why is this study important?
Brain tumors are among the most lethal types of cancer but no one knows
the exact cause. The study is investigating whether behaviors
like diet and exercise, or inherited susceptibility, play a role.
Such information can help us better understand who is at risk and how
to reduce the burden of these tumors on society.
Why is this research being done?
This study is being done at Moffitt Cancer Center and other medical
centers in the Southeastern United States to determine if there
are any genetic or environmental factors that might contribute to
the occurrence of brain tumors in adults.
Why the Southeastern United States?
The Southeast has a higher number of individuals diagnosed with brain
tumors compared to other areas throughout the country. This study
is trying to figure out why.

Who is sponsoring the study?
The study is sponsored by the National Cancer Institute, a branch of the National
Institutes of Health.
What is a Case-Control study?
This study is called a case-control study. This means that people
with brain tumors (the ‘cases’) and people who do not have
brain tumors (the ‘controls’) will take part. By comparing
these groups of people, researchers hope to find out why certain people
are at higher risk of developing these tumors.
Why am I being asked to participate?
If you have been diagnosed with a brain tumor, we are asking you
to participate as a case. If you do not have a
brain tumor, we are asking you to participate as a control. If
you were selected as a control, you may know someone who was diagnosed
with a brain tumor or you may have been randomly selected from a list
of households with published telephone numbers in your area.
Why did I get a letter in the mail?
If you received our letter you are being asked to serve as a control in
the study. Your household was randomly selected from a list of published
addresses and telephone numbers in your area. As a control, you (or someone
in your family) would represent persons from your general community of
a specific gender and age.
I don’t have a brain tumor – why am I being asked to participate?
In addition to the brain tumor patients who are being enrolled, we
need to enroll family, friends and people from the community without
a brain tumor to serve as controls. By comparing these groups
(persons with- and without brain tumors), we hope to find out why certain
people are more likely to get brain tumors, and how the disease may
be prevented in the future.
How long will it take?
This study will require no more than 1-2 hours of your time in total. If
you are participating as a control, the study will be
completed over the phone and through the mail - there is no travel
required. If
you are participating as a case, the research will typically
be scheduled before or after one of your regular visits to the clinic.
What will I need to do?
If you decide to participate in this study, you will be asked to
take part in an interview that will cover your medical history, your
lifestyle behaviors and your general background. You may skip any
questions that you do not want to answer. The interview will take
about one hour to complete. In addition, we will ask you to provide
us with a saliva sample and toenail clippings. (Some participants
may also be asked to donate a urine sample.) Postage paid envelopes
will be provided to return the samples.
How many other people will take part?
We are recruiting brain tumor patients from 5 medical centers in
the Southeastern United States. In total, about 3,000 cases and
controls will take part in this study over 5 years, beginning in
the Summer of 2007.
Do I have to participate?
Your participation in the study is completely voluntary. You can
decide not to take part in this study. You can also withdraw later on if
you change your mind.
Will it cost me anything?
There will be no cost to you for participating in this study.
What are the potential benefits?
You will receive no immediate benefit, except for
the feeling of satisfaction that comes from taking part in a study
that may help others. By volunteering you are helping us learn more
about brain tumors. This knowledge may help us to understand the
causes of brain tumors and may give us insights on better treatments.
Potential benefits to medical knowledge and society at large are
substantial, as brain tumors are one of the most devastating human
cancers.
Are there any risks?
There are no risks of any kind for taking part in this study.
Is this confidential?
Yes; all information is maintained in strict confidence. Your
name will never be used. Our report will include only a summary
from all of the responses that people give us. Numerous measures
are in place to protect your information and insure confidentiality.
For example, data forms and specimens are labeled using coded numbers,
rather than your name. The protection of your information
is mandated by institutional review boards (IRB's) at every participating
institution, as well as the National Cancer Institute. These IRB's
are overseen by the Office of Human Research Protections
of the US Department of Health and Human Services (DHHS). The DHHS
imposes strict requirements on the conduct of research involving
human subjects. If you would like more information about these requirements,
please visit the DHHS website on Human Subjects’ Protections
at (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Will I get results?
Test results from the study are for medical research, and will be
of no value to you. Therefore, no individual test results will
be released. Results from the study will be available in several years.
This website will be updated as the study results are published. Please
feel free to check-in periodically to keep track of the progress of the
study.
How can I get more information about the study?
You can call our toll free number (1-800-226-5966) or email us at info@southeasternbraintumorstudy.org.
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