Women Who Are At Risk Or May Have Lynch Syndrome - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00508573

Purpose

Primary Objectives:

To create a registry of women who have or are at risk for Lynch syndrome, and to monitor and document their follow-up prospectively.
To have a repository of clinical data and tissue specimens that will serve as a secure archive for future research.

Condition	Intervention
Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome	Behavioral: Questionnaire

Genetics Home Reference related topics: Lynch syndrome

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Registry for Women Who Are At Risk Or May Have Lynch Syndrome

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this study is to create a registry of information about women who have or are at risk for Lynch syndrome, in order to study gynecologic cancer risks. [ Time Frame: 30 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Leftover tissue samples will be collected from your surgery if you have had surgery. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors.

Estimated Enrollment:	9999
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2037 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patient that has or is at risk for Lynch Syndrome.	Behavioral: Questionnaire Follow-up questionnaire done once a year for five years.

Detailed Description:

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 M. D. 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 M. D. 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 M. D. 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. . There is no maximum accrual for this study. All patients will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient that has or is at risk for Lynch Syndrome.

Criteria

Inclusion Criteria:

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

Exclusion:

1) None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508573

Contacts

Contact: Karen H. Lu, MD

713-745-8902

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen H. Lu, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Karen H. Lu, MD

U.T.M.D. Anderson Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Karen H. Lu, MD/Associate Professor )
Study ID Numbers:	2006-0973
Study First Received:	July 26, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00508573
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Hereditary Nonpolyposis Colorectal Cancer
Lynch Syndrome
HNPCC

Syndrome Registry
Questionnaire
Survey

Study placed in the following topic categories:

Digestive System Neoplasms
Metabolic Diseases
Gastrointestinal Diseases
Colonic Diseases
Hereditary nonpolyposis colon cancer
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Digestive System Diseases
Neoplastic Syndromes, Hereditary
Colorectal Neoplasms, Hereditary Nonpolyposis
Genetic Diseases, Inborn
Colorectal cancer, hereditary nonpolyposis, type 1
Gastrointestinal Neoplasms
Metabolic disorder
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease

Neoplasms by Site
Syndrome
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on January 16, 2009