Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment. PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.

Detailed Description
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OBJECTIVES: Primary Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer. Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients. Secondary Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients. Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients. Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients. Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients. OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling. Patients are followed at 24 hours and at 1 week. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.

Official Title
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Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: cytogenetic analysis
* Genetic: proteomic profiling
* Other: cytology specimen collection procedure
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Procedure: breast duct lavage


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer No metastatic disease No inflammatory breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 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 infection or inflammation in the breast under study No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine No severe illness Not unconscious No mental illness or handicap No nursing within the past 12 months Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior breast implantation on side of proposed lavage No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or other surgery that may disrupt the ductal systems within 2 cm of the nipple Biopsies and fine-needle aspirations > 2 cm from the nipple are allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Genetic: proteomic profiling|nan|
|Other: cytology specimen collection procedure|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: breast duct lavage|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings |  |  | 
| Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells |  |  | 
| Comparison of cell yields vs final surgical pathology of the operative specimens |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IA breast cancer, stage IB breast cancer