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Registry for Women Who Are At Risk Or May Have Lynch Syndrome

This study is currently recruiting participants.
Verified November 2016 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508573
First Posted: July 30, 2007
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
July 26, 2007
July 30, 2007
November 17, 2016
May 2007
May 2018   (Final data collection date for primary outcome measure)
Number of Women Participating in Registry [ Time Frame: 5 Years ]
Not Provided
Complete list of historical versions of study NCT00508573 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Registry for Women Who Are At Risk Or May Have Lynch Syndrome
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.

Objectives:

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

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 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Leftover tissue samples will be collected from surgery performed. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors.
Non-Probability Sample
Women, 18 years or older, that have or are at risk for Lynch Syndrome.
  • Hereditary Nonpolyposis Colorectal Cancer
  • Lynch Syndrome
Behavioral: Questionnaire
Follow-up questionnaire done once a year for five years.
Other Name: Survey
Lynch Syndrome Registry
Patient that has or is at risk for Lynch Syndrome.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
May 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Karen H. Lu, MD 713-745-8902
United States
 
 
NCT00508573
2006-0973
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2016