Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer

University of Sheffield

Status: Unknown

Conditions: Breast Cancer

Treatments: Genetic: polymorphism analysis; Genetic: microarray analysis; Other: laboratory biomarker analysis; Other: questionnaire administration; Genetic: polymerase chain reaction; Other: immunohistochemistry staining method; Other: high performance liquid chromatography

Study type: Observational

Funder types: Other

Identifiers

NCT00463034

SHEFF-USMS-05/Q2308/15

SHEFF-106364

SHEFF-05/Q2308/15

GENFABRCA

SHEFF-STH13824

CDR0000540737

EU-20726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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