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

NCT00478686 | Completed

• 1 other identifier: 2006-1003
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of DPYD variants in patients

  2 Years

Study Arms (3)

Severe Toxicity

Patients who experienced severe toxicity (at least one grade 4 side effect) with capecitabine chemotherapy

Procedure: Phlebotomy

Dose-Limiting Toxicity

Patients who experienced dose-limiting toxicity (at least one grade 3, or recurrent grade 2, side effect)with capecitabine chemotherapy

Procedure: Phlebotomy

Low/No Toxicity

Patients who have experienced low/no toxicity (none or only side effects at grade 1 \& 2) with capecitabine chemotherapy.

Procedure: Phlebotomy

Interventions

Phlebotomy PROCEDURE

5 to 7.5 milliliter (mL) Blood Sample

Dose-Limiting Toxicity; Low/No Toxicity; Severe Toxicity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with breast cancer who experienced toxicity/side effects related to capecitabine chemotherapy.

You may qualify if:

• Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study.
• Patients must sign an informed consent for this protocol.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Myrexis Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

5 to 7.5 milliliter (mL) sample of blood. Alternatively, DNA will be extracted from 10um slices of formalin-fixed paraffin-embedded tissue from previously collected tumor tissue (from the time of the breast cancer diagnosis).

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vicente Valero, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 25, 2007
• Study Start: May 23, 2007
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (1)