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

Breast Cancer Biomarkers Based on Fine Needle Aspirates

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00041353

Enrollment

Registered

2003-05-26

Start date

Unknown

Completion date

2002-09-30

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ, lobular breast carcinoma in situ

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.

Interventions

OTHERcytology specimen collection procedure

PROCEDUREcomparison of screening methods

PROCEDUREstudy of high risk factors

Study design

Primary purpose

SCREENING

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

Healthy volunteers

Inclusion 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 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026