![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00508573 |
Primary Objectives:
Condition | Intervention |
---|---|
Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Registry for Women Who Are At Risk Or May Have Lynch Syndrome |
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patient that has or is at risk for Lynch Syndrome.
Inclusion Criteria:
Exclusion:
1) None
Contact: Karen H. Lu, MD | 713-745-8902 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Karen H. Lu, MD |
Principal Investigator: | Karen H. Lu, MD | U.T.M.D. Anderson Cancer Center |
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 |
Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome HNPCC |
Syndrome Registry Questionnaire Survey |
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 |
Neoplasms Pathologic Processes Disease |
Neoplasms by Site Syndrome DNA Repair-Deficiency Disorders |