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

18 Years
Open (Enrolling)
Hereditary Nonpolyposis Colorectal Cancer, Lynch Syndrome

Thank you

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

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.

Inclusion Criteria:

1. Women who meet one or more of the following criteria:

A. Lynch syndrome mutation, including those at risk for cancer, those who have had
cancer, and those who have had prophylactic surgery.

B. Family history meets Amsterdam II criteria, defined as the following: At least 3
relatives with an HNPCC-associated cancer (colorectal.endometrial cancer, small
bowel, ureter, or renal pelvis). One is a first-degree relative of the other two. At
least 2 successive generations affected. One cancer diagnosed before age 50.

C. Tumor studies (MSI, IHC) are suggestive for Lynch Syndrome.

D. Female family members who are at 25% or 50% risk for a lynch syndrome mutation may
also be enrolled in the registry. 25% risk is defined as women with second degree
family member grandmother, aunt, uncle, niece, and grandchild. 50% risk is defined as
women with first degree family member being parent, child, sibling.

2. Subjects must be 18 or older and able to give informed consent.

Exclusion Criteria:

1) None

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Number of Women Participating in Registry

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Karen H. Lu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Hereditary Nonpolyposis Colorectal Cancer
  • Lynch Syndrome
  • Hereditary Nonpolyposis Colorectal Cancer
  • Lynch Syndrome
  • Syndrome Registry
  • Questionnaire
  • Endometrial cancer
  • Ovarian cancer
  • Colorectal Neoplasms
  • Colorectal Neoplasms, Hereditary Nonpolyposis



UT MD Anderson Cancer Center Houston, Texas  77030