Breast Cancer Clinical Trial
Official title:
Genetic Factors Affecting Breast Cancer Progression
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.
OBJECTIVES:
Primary
- Correlate inherited and acquired variations in candidate genes with breast cancer
progression and survival in women with newly diagnosed or metastatic breast cancer.
Secondary
- 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.
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