Registry for Women Who Are At Risk Or May Have Lynch Syndrome
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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. |
| ClinicalTrials.gov Identifier: NCT00508573 |
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Recruitment Status :
Recruiting
First Posted : July 30, 2007
Last Update Posted : July 11, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome | Behavioral: Questionnaire |
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 : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Registry for Women Who Are At Risk Or May Have Lynch Syndrome |
| Actual Study Start Date : | May 2007 |
| Estimated Primary Completion Date : | May 2028 |
| Estimated Study Completion Date : | May 2028 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lynch Syndrome Registry
Patient that has or is at risk for Lynch Syndrome.
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Behavioral: Questionnaire
Follow-up questionnaire done once a year for five years.
Other Name: Survey |
- Number of Women Participating in Registry [ Time Frame: 5 Years ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508573 History of Changes |
| Other Study ID Numbers: |
2006-0973 |
| First Posted: | July 30, 2007 Key Record Dates |
| Last Update Posted: | July 11, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
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Hereditary Nonpolyposis Colorectal Cancer Lynch Syndrome HNPCC Syndrome Registry |
Questionnaire Endometrial cancer Ovarian cancer |
Additional relevant MeSH terms:
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Syndrome Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Disease Pathologic Processes Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |