Spots Global Cancer Trial Database for Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer

Study Description

Brief Summary: RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment. PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.

Detailed Description: OBJECTIVES: * Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer. * Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting. * Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer. * Determine whether 1 or more biomarkers can distinguish high-risk from control patients. * Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy. OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers. PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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