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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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stage IV breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer

Interventions

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microarray analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

high performance liquid chromatography

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Angela Cox, PhD

Role: STUDY_CHAIR

University of Sheffield

Locations

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University of Sheffield School of Medicine and Biomedical Sciences

Sheffield, England, United Kingdom

Site Status

Countries

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United Kingdom