Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00463034|
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 19, 2007
Last Update Posted : December 18, 2013
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 or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1800 participants|
|Official Title:||Genetic Factors Affecting Breast Cancer Progression|
|Study Start Date :||April 2005|
|Estimated Primary Completion Date :||March 2008|
- Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival
- Establishment of a repository of blood and tumor samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463034
|University of Sheffield School of Medicine and Biomedical Sciences|
|Sheffield, England, United Kingdom, S10 2RX|
|Study Chair:||Angela Cox, PhD||University of Sheffield|