Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00478686

Enrollment

102

Registered

2007-05-25

Start date

2007-05-23

Completion date

2017-05-02

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Dihydropyrimidine Dehydrogenase, DPYD, DPYD Variants, Toxicity, Capecitabine, Xeloda

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 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.

Interventions

PROCEDUREPhlebotomy

5 to 7.5 milliliter (mL) Blood Sample

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of DPYD variants in patients	2 Years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026