Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508573
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2007-07-26
Brief Title:
Registry for Women Who Are At Risk Or May Have Lynch Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Registry for Women Who Are At Risk Or May Have Lynch Syndrome
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
This is an investigational study Up to 1000 patients will take part in this study All patients will be enrolled at MD Anderson
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None