Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00579488
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2007-12-19
Brief Title:
Clinical Significance of Germline BRCA Mutations
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Clinical Significance of Germline BRCA Mutations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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 help us learn more about the roles of genes in cancers that run in families Sometimes we are born with genes that are changed or altered Gene changes are called mutations Mutations may be passed down from parent to child Some mutations cause a high risk for cancer There are two major genes for breast and ovarian cancer These genes are called BRCA --for breast cancer If you have a mutation in these genes special actions may be needed For a person with a known mutation we will suggest ways to screen for cancer or prevent it Not everything is known about cancer genes and mutations The cancer screening we suggest may not always be effective The aim of this study is to explore these questions If you agree we will stay in touch with you to follow your medical history We will also ask you about your family
This will allow us to measure the cancer risks of known mutations The study will also look for other cancer genes we do not know about Whether or not you take part in this study you may have gene testing If you take part in this study and wish to know we will tell your BRCA gene test results
Beginning in 2019 a subset of participants will be given a follow-up questionnaire regarding their health and well-being
The investigators may perform genetic testing on the blood or saliva sample in one of two ways analysis for mutations in the BRCA1 and BRCA2 genes alone or as part of a panel of genes associated with breast cancer predisposition New technologies are being employed for identification of patients with a susceptibility for developing breast cancer and thus analysis of multiple genes at one time may be offered to you If this multi-gene testing applies to the patient a question and answer sheet about this testing will be provided to them by their genetic counselor
This will allow us to measure the cancer risks of known mutations The study will also look for other cancer genes we do not know about Whether or not you take part in this study you may have gene testing If you take part in this study and wish to know we will tell your BRCA gene test results
Beginning in 2019 a subset of participants will be given a follow-up questionnaire regarding their health and well-being
The investigators may perform genetic testing on the blood or saliva sample in one of two ways analysis for mutations in the BRCA1 and BRCA2 genes alone or as part of a panel of genes associated with breast cancer predisposition New technologies are being employed for identification of patients with a susceptibility for developing breast cancer and thus analysis of multiple genes at one time may be offered to you If this multi-gene testing applies to the patient a question and answer sheet about this testing will be provided to them by their genetic counselor
Detailed Description:
None
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