Pancreatic Cancer Clinical Trial
Official title:
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.
Participants in this study will be part of a pancreatic cancer genetic epidemiology
consortium (herein referred to as "PACGENE"), which includes researchers at these
institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of
Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have
either been diagnosed with pancreatic cancer or are family members of pancreatic cancer
patients.
Participants will be asked questions by a trained interviewer using an approved
questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical
history data, family history of cancer and other conditions, and other lifestyle factors. It
should take about 30-40 minutes to complete the questionnaire.
Participants in this study will also have about one and a half tablespoons of blood drawn.
Blood that is collected will only be used by researchers involved in this study. If obtaining
a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE
kit. Neither participants nor their physicians will receive individual reports of this
research. Results will not be placed in the participant's health records. All information
will be kept confidential and used only for this research.
There is a rare chance that a research team member could be accidentally exposed to your
blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test
for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be
used for these tests instead. You will be told that your blood is being tested and the
results of your test. Researchers will ask how you would like to receive the results, such as
by phone or certified letter. The test results and your name, address, date of birth, and sex
will be recorded in the confidential M. D. Anderson medical records.
If you test positive for hepatitis or HIV, the test results and your name, address, date of
birth, and sex will be shared with appropriate health authorities as required by law. You
will also be given a list of places in your area so that you can receive further testing and
treatment.
For the protection of your privacy, the study staff has obtained a Certificate of
Confidentiality from the National Institutes of Health. With this certificate, the
researchers cannot be forced to disclose information that may identify you, even by a court
subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or
other proceedings. The researchers will use the certificate to resist any demands for
information that would identify you, except as explained below.
The certificate cannot be used to resist a demand for information from personnel of the
United State Government that is used for auditing or evaluation of Federally funded projects
or for information that must be disclosed in order to meet the requirements of the federal
Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member
of your family from voluntarily releasing information about yourself or your involvement in
this research. If an insurer, employer, or other person obtains your written consent to
receive research information, then the researchers may not use the certificate to withhold
that information.
This is an investigational study. This study will include a total of 1,000 participants
recruited at M. D. Anderson.
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