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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

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.

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.

Study Design

Primary Purpose: Screening

Conditions

Breast Cancer

Intervention

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

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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