NCT00291096招募中不适用
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Carol Fabian, MD1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2006年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Prediction of risk for developing breast cancer
研究概览
简要总结
The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.
详细描述
- To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail risk estimates. Where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included.
- To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
- To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER, COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc), proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone levels, and correlate them with other risk biomarkers listed in 1.
- To determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as DNA repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of DCIS and invasive cancer.
- To maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with at least 2 times the normal risk of developing breast cancer
- •between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
- •greater than six months from ingestion of antihormonal therapy
- •greater than 1 year from pregnancy, lactation, or chemotherapy
- •willing to have a mammogram within six months prior to RPFNA
- •willing to discontinue NSAIDS or herbal supplements
- •willing to have blood drawn
排除标准
- •no metastatic malignancy of any kind
- •no breast implants or tram flap reconstructions
- •no radiation to both breasts
- •no women who have a current mammogram or clinical breast exam suspicious for cancer
结局指标
主要结局
Prediction of risk for developing breast cancer
时间窗: ongoing
development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.
次要结局
未报告次要终点
研究者
Carol Fabian, MD
Professor
University of Kansas Medical Center
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Women At Risk: The High Risk Breast Cancer ProgramBreast CancerNCT01034891New York Presbyterian Hospital2,000
Unknown
不适用
High Risk Breast Cancer Screening ProgramBreast CancerNCT00509509Organisation for Oncology and Translational Research
已完成
不适用
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing EquityBreast CancerNCT05051631Vanderbilt University Medical Center1,071
已完成
不适用
Intervention to Promote Breast Cancer Screening Among American Indian WomenBreast CancerNCT05530603University of South Dakota133
招募中
不适用
Breast CANcer Risk Assessment in Younger Women: BCAN-RAYBreast Cancer FemaleNCT05305963Manchester University NHS Foundation Trust1,000