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临床试验/NCT01248546
NCT01248546Unknown不适用

Digital Breast Tomosynthesis in the Oslo Mammography Screening Program

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 25,000 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25,000
试验地点
1
主要终点
Screening performance indicators

研究概览

简要总结

The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.

Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.

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
50 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 50 to 69 years who have signed the informed consent

排除标准

  • Women with pacemaker, implants, and severely disabled

结局指标

主要结局

Screening performance indicators

时间窗: From Nov. 22, 2010 to Dec. 31, 2012

次要结局

  • Interval cancer rate(From Nov. 23, 2010 to Dec. 31, 2014)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Skaane

professor dr. med.

Oslo University Hospital

研究点 (1)

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