Breast Cancer
Conditions
Keywords
stage IV breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief summary
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.
Detailed description
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.
Interventions
GENETICmicroarray analysis
GENETICpolymerase chain reaction
GENETICpolymorphism analysis
OTHERhigh performance liquid chromatography
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
OTHERquestionnaire administration
Sponsors
University of Sheffield
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Newly diagnosed or metastatic disease * Resides within the North Trent Cancer Network (NTCRN) region * Undergoing therapy at NTCRN centers * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified PRIOR CONCURRENT THERAPY: * No concurrent participation in another genetic study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Establishment of a repository of blood and tumor samples | — |
Countries
United Kingdom
Outcome results
None listed