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Home > "C" Clinical Trials Conditions > Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
For Condition: Diagnostic Techniques and Procedures,Cancer of the Breast
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting. III. Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer. IV. Determine whether 1 or more biomarkers can distinguish high-risk from control patients. V. Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy. PROTOCOL 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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 30 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR - No increased risk of breast cancer as determined by a lack of the above conditions - Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump - No prior bilateral mastectomy or bilateral breast irradiation - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics --Patient Characteristics-- Age: 30 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: - No active invasive malignancy in any site except basal cell or squamous cell skin cancer - No significant medical or psychiatric problems that would preclude study - No evidence of excessive use of narcotics or drug dependency
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelTorosian, Study Chair, Fox Chase Cancer Center
Additional Information:
Study ID Numbers: CDR0000069491; NCI-G02-2095,FCCC-02010
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041353
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1. Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
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Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
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