- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508573
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.
This is an investigational study. Up to 1000 patients will take part in this study. All patients will be enrolled at MD Anderson.
Study Overview
Status
Intervention / Treatment
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 20 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 active participation in this study will continue for up to 20 years total.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Karen H. Lu, MD
- Phone Number: 713-745-8902
- Email: khlu@mdanderson.org
Study Locations
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-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
-
Principal Investigator:
- Karen H. Lu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Criteria:
1) None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lynch Syndrome Registry
Patient that has or is at risk for Lynch Syndrome.
|
Follow-up questionnaire done once a year for five years.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Women Participating in Registry
Time Frame: 5 Years
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen H. Lu, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Disease
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Syndrome
- Colorectal Neoplasms
- Colorectal Neoplasms, Hereditary Nonpolyposis
Other Study ID Numbers
- 2006-0973
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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