Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer. PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy. Secondary Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants. Determine cancer risk and incidence utilizing these methods of screening in these participants. Observe the natural history of atypia in these participants over a total of 10 years. Determine whether these techniques may serve as supplementary tools in future screening of these participants. OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years. Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy. Participants are followed annually for a total of 10 years. PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.

Official Title
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The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: protein expression analysis
* Other: cytology specimen collection procedure
* Other: laboratory biomarker analysis
* Other: physiologic testing
* Procedure: breast duct lavage
* Procedure: endoscopic biopsy
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer No concurrent inflammatory breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 to 64 Sex Female Menopausal Status Premenopausal or postmenopausal Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No prior allergy to EMLA cream or lidocaine No severe illness that would preclude study participation No mental illness or handicap that would preclude study compliance No concurrent active infection or inflammation in the breast being studied Not unconscious Not pregnant No nursing within the past 12 months PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple No prior breast implantation on proposed lavage side

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: protein expression analysis|nan|
|Other: cytology specimen collection procedure|nan|
|Other: laboratory biomarker analysis|nan|
|Other: physiologic testing|nan|
|Procedure: breast duct lavage|nan|
|Procedure: endoscopic biopsy|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer