Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in women with newly diagnosed or metastatic breast cancer.
Genetic: microarray analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: high performance liquid chromatography
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: questionnaire administration
|Official Title:||Genetic Factors Affecting Breast Cancer Progression|
- Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival [ Designated as safety issue: No ]
- Establishment of a repository of blood and tumor samples [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- Correlate inherited and acquired variations in candidate genes with breast cancer progression and survival in women with newly diagnosed or metastatic breast cancer.
- Establish a repository of blood and tumor samples from these patients, linked to a database of clinical, pathological, and treatment outcome data for future research studies.
OUTLINE: Patients complete epidemiological questionnaires and undergo blood sample collection. Tumor tissue specimens are requested from the pathology departments.
Blood samples are analyzed for single nucleotide polymorphisms and other polymorphic variants in candidate genes by polymerase chain reaction. Candidate genes include genes involved in the DNA damage response, programed cell death, inflammation, and angiogenesis. Tumor samples are analyzed by tissue microarrays using immunohistochemistry, denaturing high-performance liquid chromatography, and DNA sequencing to study genetic changes in the tumor.
PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463034
|University of Sheffield School of Medicine and Biomedical Sciences|
|Sheffield, England, United Kingdom, S10 2RX|
|Study Chair:||Angela Cox, PhD||University of Sheffield|