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Sponsored by: |
University of Sheffield |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00463034 |
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.
Condition | Intervention |
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Breast Cancer |
Procedure: gene expression profiling Procedure: high performance liquid chromatography Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: polymerase chain reaction Procedure: polymorphism analysis Procedure: questionnaire administration |
Study Type: | Observational |
Official Title: | Genetic Factors Affecting Breast Cancer Progression |
Estimated Enrollment: | 1800 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
University of Sheffield School of Medicine and Biomedical Sciences | |
Sheffield, England, United Kingdom, S10 2RX |
Study Chair: | Angela Cox, PhD | University of Sheffield |
Study ID Numbers: | CDR0000540737, SHEFF-05/Q2308/15, SHEFF-USMS-05/Q2308/15, EU-20726, SHEFF-STH13824, SHEFF-106364, GENFABRCA |
Study First Received: | April 18, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00463034 |
Health Authority: | United States: Federal Government |
stage IV breast cancer stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Skin Diseases Disease Progression Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |