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| ID | Type | Description | Link |
|---|---|---|---|
| SHEFF-05/Q2308/15 | |||
| SHEFF-USMS-05/Q2308/15 | |||
| EU-20726 | |||
| SHEFF-STH13824 | |||
| SHEFF-106364 | |||
| GENFABRCA |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microarray analysis | Genetic | |||
| polymerase chain reaction | Genetic | |||
| polymorphism analysis | Genetic | |||
| high performance liquid chromatography | Other | |||
| immunohistochemistry staining method | Other | |||
| laboratory biomarker analysis | Other | |||
| questionnaire administration | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a repository of blood and tumor samples |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Resides within the North Trent Cancer Network (NTCRN) region
Undergoing therapy at NTCRN centers
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Cox, PhD | University of Sheffield | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sheffield School of Medicine and Biomedical Sciences | Sheffield | England | S10 2RX | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D046228 | Microarray Analysis |
| D016133 | Polymerase Chain Reaction |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D002851 | Chromatography, High Pressure Liquid |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D046208 | Microchip Analytical Procedures |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D016172 | DNA Fingerprinting |
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
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