Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00776958
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2008-10-20
Brief Title:
Lynne Cohen Consortium Project Multi-Center DatabaseRegistry
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Multi - Center DatabaseRegistry of Subjects at High Risk for Ovarian or Breast Cancer - A Lynne Cohen Consortium Project
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Goals of this registry
11 To collect and store very limited demographic information age birthdate race and ethnicity limited cancer risk and breast and ovarian disease history as well as limited family history of breast and ovarian cancer on patients who are at risk of breast or ovarian cancer or who have had a diagnosis of either cancer
12 To make available summary information in an anonymous form regarding the subjects in this registry to Consortium members and other investigators who can use these data to plan research projects and evaluate the feasibility of such projects
13 To make available summary information number of new patients seen in the clinic number of mutations number of preventive surgeries average age of patients seen to the Lynne Cohen Foundation for Ovarian Cancer Research in order to document the numbers of subjects who utilize their supported clinics
11 To collect and store very limited demographic information age birthdate race and ethnicity limited cancer risk and breast and ovarian disease history as well as limited family history of breast and ovarian cancer on patients who are at risk of breast or ovarian cancer or who have had a diagnosis of either cancer
12 To make available summary information in an anonymous form regarding the subjects in this registry to Consortium members and other investigators who can use these data to plan research projects and evaluate the feasibility of such projects
13 To make available summary information number of new patients seen in the clinic number of mutations number of preventive surgeries average age of patients seen to the Lynne Cohen Foundation for Ovarian Cancer Research in order to document the numbers of subjects who utilize their supported clinics
Detailed Description:
Information Collection for Entry into Multicenter Registry
If you agree to take part in this study a study staff member will collect the following information by asking you at a clinic visit and checking your medical records The following information will be entered in the registry
your demographic information your sex year of birth and raceethnicity whether any member of your family has a history of ovarian andor breast cancer whether any member of your family has any known genetic markers that may mean a higher risk of developing a cancer a brief summary of your history of breast andor ovarian disease and whether you have any known genetic markers that may mean a higher risk of developing breast andor ovarian cancer a brief summary of the results of the clinic visit on the day you agreed to take part in this study Day 1
Follow-Up Information Collection
Each time you visit the M D Anderson high-risk clinic either the high-risk breast cancer clinic or the high-risk ovarian cancer clinic the study staff will check your medical records and enter in the registry any updates to your cancer risk information You will also be asked if any family members have been diagnosed with ovarian andor breast cancer and this will be entered in the registry
If you miss any of your planned clinic visits the study staff may contact you by phone to collect this information contact you by mail to send you a questionnaire with this information andor reschedule your appointment If you receive a questionnaire by mail you will fill it out and mail it back to the research staff in the stamped self-addressed envelope that will be provided to you It should take about 5-10 minutes to complete
Study Data
The study staff plans to keep all personal identifying information such as your name strictly confidential Your data will be handwritten on paper forms that will be stored in a locked file cabinet The study staff will enter your data into the multicenter database registry with your participant identification ID number but not your name or other identifying information The registry is password-protected Only designated members of the study staff will have access to the participant ID numbers and be able to link the data to you This is to allow medical information related to your data to be updated as needed The linking information will be saved securely on a password-protected computer in the research office
The multicenter registry is called the Lynne Cohen registry It is maintained at the University of Southern California Norris Comprehensive Cancer Center
Use of Registry for Planning Future Research
Lynne Cohen clinics make up the multicenter group of clinics that are involved in this study If a researcher at any Lynne Cohen clinic is planning to perform a research study involving ovarian or breast cancer causes or prevention he or she can contact the Lynne Cohen Foundation A staff member at the Lynne Cohen Foundation will check to see how many patients are included in the registry This will help the researcher find out how many people the researcher may be able to ask to join his or her study That number of people will also help the researcher decide if the planned study is feasible The number of patients in the registry is the only information that will be shared with these researchers
Length of Study Participation
Your participation in this study will last for as long as you agree to keep having this study information collected
When your participation in this study ends the M D Anderson study staff will delete or destroy any personal identifying information and contact information collected The rest of the study data will continue being stored in the registry
This is an investigational study
Up to 1000 patients will be enrolled in this multicenter study Up to 200 will be enrolled at M D Anderson
If you agree to take part in this study a study staff member will collect the following information by asking you at a clinic visit and checking your medical records The following information will be entered in the registry
your demographic information your sex year of birth and raceethnicity whether any member of your family has a history of ovarian andor breast cancer whether any member of your family has any known genetic markers that may mean a higher risk of developing a cancer a brief summary of your history of breast andor ovarian disease and whether you have any known genetic markers that may mean a higher risk of developing breast andor ovarian cancer a brief summary of the results of the clinic visit on the day you agreed to take part in this study Day 1
Follow-Up Information Collection
Each time you visit the M D Anderson high-risk clinic either the high-risk breast cancer clinic or the high-risk ovarian cancer clinic the study staff will check your medical records and enter in the registry any updates to your cancer risk information You will also be asked if any family members have been diagnosed with ovarian andor breast cancer and this will be entered in the registry
If you miss any of your planned clinic visits the study staff may contact you by phone to collect this information contact you by mail to send you a questionnaire with this information andor reschedule your appointment If you receive a questionnaire by mail you will fill it out and mail it back to the research staff in the stamped self-addressed envelope that will be provided to you It should take about 5-10 minutes to complete
Study Data
The study staff plans to keep all personal identifying information such as your name strictly confidential Your data will be handwritten on paper forms that will be stored in a locked file cabinet The study staff will enter your data into the multicenter database registry with your participant identification ID number but not your name or other identifying information The registry is password-protected Only designated members of the study staff will have access to the participant ID numbers and be able to link the data to you This is to allow medical information related to your data to be updated as needed The linking information will be saved securely on a password-protected computer in the research office
The multicenter registry is called the Lynne Cohen registry It is maintained at the University of Southern California Norris Comprehensive Cancer Center
Use of Registry for Planning Future Research
Lynne Cohen clinics make up the multicenter group of clinics that are involved in this study If a researcher at any Lynne Cohen clinic is planning to perform a research study involving ovarian or breast cancer causes or prevention he or she can contact the Lynne Cohen Foundation A staff member at the Lynne Cohen Foundation will check to see how many patients are included in the registry This will help the researcher find out how many people the researcher may be able to ask to join his or her study That number of people will also help the researcher decide if the planned study is feasible The number of patients in the registry is the only information that will be shared with these researchers
Length of Study Participation
Your participation in this study will last for as long as you agree to keep having this study information collected
When your participation in this study ends the M D Anderson study staff will delete or destroy any personal identifying information and contact information collected The rest of the study data will continue being stored in the registry
This is an investigational study
Up to 1000 patients will be enrolled in this multicenter study Up to 200 will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None