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NCT00478686 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00478686
Other study ID # 2006-1003
Secondary ID
Status Completed
Phase N/A
First received May 23, 2007
Last updated May 4, 2017
Start date May 23, 2007
Est. completion date May 2, 2017

Study information
Verified date May 2017
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date May 2, 2017
Est. primary completion date May 2, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Phlebotomy
5 to 7.5 milliliter (mL) Blood Sample

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of DPYD variants in patients 2 Years
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