Registry for Women Who Are At Risk Or May Have Lynch Syndrome
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.
- 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.
|Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome||Behavioral: Questionnaire|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Registry for Women Who Are At Risk Or May Have Lynch Syndrome|
- Number of Women Participating in Registry [ Time Frame: 5 Years ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||May 2007|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Lynch Syndrome Registry
Patient that has or is at risk for Lynch Syndrome.
Follow-up questionnaire done once a year for five years.
Other Name: Survey
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%.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508573
|Contact: Karen H. Lu, MD||713-745-8902|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Karen H. Lu, MD|
|Principal Investigator:||Karen H. Lu, MD||M.D. Anderson Cancer Center|