Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
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.
|Breast Cancer||Other: cytology specimen collection procedure Procedure: comparison of screening methods Procedure: study of high risk factors|
|Study Design:||Primary Purpose: Screening|
|Official Title:||Breast Cancer Biomarkers Based on Fine Needle Aspirates|
|Study Completion Date:||September 2002|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041353
|Study Chair:||Michael H. Torosian, MD||Fox Chase Cancer Center|