This trial is active, not recruiting.

Condition breast cancer
Treatments microarray analysis, polymerase chain reaction, polymorphism analysis, high performance liquid chromatography, immunohistochemistry staining method, laboratory biomarker analysis, questionnaire administration
Sponsor University of Sheffield
Start date April 2005
End date March 2008
Trial size 1800 participants
Trial identifier NCT00463034, CDR0000540737, EU-20726, GENFABRCA, SHEFF-05/Q2308/15, SHEFF-106364, SHEFF-STH13824, SHEFF-USMS-05/Q2308/15


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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival
time frame:

Secondary Outcomes

Establishment of a repository of blood and tumor samples
time frame:

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Genetic Factors Affecting Breast Cancer Progression
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).