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A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine


N/A
N/A
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to 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.


Inclusion Criteria:



1. Patients must be registered for protocol ID01-580 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Incidence of DPYD variants in patients

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Phuong K. Morrow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-1003

NCT ID:

NCT00478686

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Dihydropyrimidine Dehydrogenase
  • DPYD
  • DPYD Variants
  • Toxicity
  • Capecitabine
  • Xeloda
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030