Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/4/2017 |
| Start Date: | May 2007 |
| End Date: | May 2018 |
A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
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.
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.
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 and/or 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 and/or 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.
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 and/or 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 and/or 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.
Inclusion Criteria:
1. Patients must be registered for protocol ID 01-580 and only patients who were
randomized to receive capecitabine will be included in the study.
2. Patients must sign an informed consent for this protocol.
Exclusion Criteria:
1) There are no exclusion criteria.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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