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临床试验/NCT04002986
NCT04002986已完成不适用

Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
116
试验地点
2
主要终点
Genetic mutations

研究概览

简要总结

Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women participating in IRB:18-010601
  • Aged 35 and over with a negative routine mammogram within 3 months.
  • Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).
  • Have an active email address for survey completion

排除标准

  • Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
  • Known genetic cancer syndrome with test results available for review in Mayo EMR
  • Known breast cancer
  • Unable to understand or sign informed consent

结局指标

主要结局

Genetic mutations

时间窗: One year

Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)

Study Participants

时间窗: One year

Number of subjects who decide to undergo genetic panel testing

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Niloy Jewel (Jewel) Samadder

Principal Investigator

Mayo Clinic

研究点 (2)

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