Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer

2014-08-27 03:55:58 | BioPortfolio


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.



- 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.

Study Design

Primary Purpose: Screening


Breast Cancer


cytology specimen collection procedure, comparison of screening methods, study of high risk factors




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:55:58-0400

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