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临床试验/NCT00555503
NCT00555503已完成不适用

Registry of Mastectomy for Breast Cancer Risk Reduction

Georgetown University1 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
261
试验地点
1
主要终点
The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up.

研究概览

简要总结

This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at an elevated risk for breast cancer.

排除标准

  • 未提供

结局指标

主要结局

The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up.

时间窗: 10 years

次要结局

  • Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott L. Spear, M.D.

Chief Plastic Surgery

Georgetown University

研究点 (1)

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