Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478686
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2007-05-23
Brief Title:
Association of Dihydropyrimidine Dehydrogenase DPYD Variants With Toxicity Related to Capecitabine
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase DPYD Variants With Toxicity Related to Capecitabine
Status:
COMPLETED
Status Verified Date:
2017-05
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 laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine
Detailed Description:
If you agree to take part in this study 1 blood sample about 2 tablespoons will be drawn for use in genetic research
If you are unable to provide a blood sample researchers will collect leftover tissue samples from your previously collected tumor tissue from the time of the breast cancer diagnosis The tumor samples will be used for genetic research
After the blood draw or tissue collection your participation in this study will be over
The blood samples for the genetic research will be stored at Myriad Laboratories Before your blood andor tissue is sent to Myriad Laboratories for banking your name and any personal identifying information will be coded to protect your privacy M D Anderson will not have oversight of any leftover tissue andor blood that will be banked by Myriad Laboratories for additional research
This is an investigational study Up to 210 patients will take part in this study All will be enrolled at M D Anderson
If you are unable to provide a blood sample researchers will collect leftover tissue samples from your previously collected tumor tissue from the time of the breast cancer diagnosis The tumor samples will be used for genetic research
After the blood draw or tissue collection your participation in this study will be over
The blood samples for the genetic research will be stored at Myriad Laboratories Before your blood andor tissue is sent to Myriad Laboratories for banking your name and any personal identifying information will be coded to protect your privacy M D Anderson will not have oversight of any leftover tissue andor blood that will be banked by Myriad Laboratories for additional research
This is an investigational study Up to 210 patients will take part in this study All will be enrolled at M D Anderson
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