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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00508573
Other study ID # 2006-0973
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2007
Est. completion date May 2029

Study information

Verified date December 2020
Source M.D. Anderson Cancer Center
Contact Karen H. Lu, MD
Phone 713-745-8902
Email khlu@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date May 2029
Est. primary completion date May 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. 2. 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. 3. Subjects must be 18 or older and able to give informed consent. Exclusion Criteria: 1) None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire
Follow-up questionnaire done once a year for five years.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Women Participating in Registry 5 Years
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