Trials / Withdrawn
WithdrawnNCT00041353
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- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Fox Chase Cancer Center · Academic / Other
- Sex
- Female
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | cytology specimen collection procedure | |
| PROCEDURE | comparison of screening methods | |
| PROCEDURE | study of high risk factors |
Timeline
- Primary completion
- 2002-09-01
- Completion
- 2002-09-01
- First posted
- 2003-05-26
- Last updated
- 2013-07-11
Source: ClinicalTrials.gov record NCT00041353. Inclusion in this directory is not an endorsement.