Trial Information

Registry for Women Who Are At Risk Or May Have Lynch Syndrome

Lynch Syndrome:

In women with hereditary non-polyposis colorectal cancer syndrome (HNPCC), also called Lynch
syndrome, the lifetime risk for endometrial cancer increases to 40-60%, and the risk for
ovarian cancer increases to 12%.

Study Procedures:

If you agree to take part in this study, basic medical and family information will be
collected. You will be asked to fill out a baseline (starting) questionnaire, which will
ask personal information such as age, ethnic background, medical and family history, and
health habits. All information will be kept confidential. Some information may be gathered
from your medical record. It should take about 30 minutes to complete this questionnaire.

Once a year for 5 years, you will be asked to complete a follow-up questionnaire. The
follow-up questionnaire provides researchers with an opportunity to study possible health
issues and/or changes that may have occurred since your last visit. This questionnaire
should only take about 15 -20 minutes to complete.

If you have a history of endometrial or ovarian cancer, or develop endometrial or ovarian
cancer while on study, researchers will collect copies of the diagnostic and surgery reports
from your medical record and will ask you to fill out an additional questionnaire about
symptoms of endometrial cancer. This should only take about 15 minutes to complete.

Researchers will also collect several leftover tissue samples from your surgery if you have
had surgery. These samples will be stored and used to perform molecular studies to
characterize Lynch syndrome tumors. The samples will be kept securely in a lab at MD
Anderson.

Before your leftover tissue samples can be used for research, the people doing the research
must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The
IRB is a committee made up of doctors, researchers, and members of the community. The IRB
is responsible for protecting the participants involved in research studies and making sure
all research is done in a safe and ethical manner. All research done at MD Anderson,
including research involving your leftover tissue samples must first be approved by the IRB.

Length of Study:

At the end of the study, you may be invited to participate in a follow-up study. During
your participation in this registry study, researchers will inform you about related studies
for which you might be eligible. You will have the option to take part or not to take part
in them. Your participation in this study will be over after 5 years.

This is an investigational study. Up to 1000 patients will take part in this study. All
patients will be enrolled at MD Anderson.