NCT00081003已完成不适用
The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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:
- •Menopausal Status
- •Premenopausal or postmenopausal
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •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
- •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
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast CancerBreast CancerNCT00083018Royal Marsden NHS Foundation Trust100
已完成
不适用
Study of Ductal Lavage in Women at High Risk for Breast CancerBreast CancerNCT00429988University of California, San Francisco30
Unknown
2 期
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast CancerBreast CancerNCT00082979Royal Marsden NHS Foundation Trust60
已完成
不适用
A surveillance study of branch duct intraductal papillary mucinous neoplasm of the pancreas; a multicenter prospective study.Branch duct intraductal mucinous papillary neoplasm of pancreas (BD-IPMN)JPRN-UMIN000007349Japan Pancreas Society2,000
已完成
不适用
Nuclear Morphology of Breast Cells in Ductal LavageBenign Breast DiseaseNCT00259597University of Michigan57