临床性能和实用性:一个微模拟模型,用于为多种癌症早期检测试验的查试验的设计提供信息
James Y Dai1, Jing Zhang1, Jerome V Braun2
1GRAIL, LLC, Menlo Park, CA, USA.
Journal of medical screening
|February 2, 2024
概括
这项研究使用微模拟模型来评估多种癌症早期检测 (MCED) 测试. 结果显示,MCED查可以增加早期癌症检测并降低死亡率,指导未来的试验设计.
科学领域:
- 在瘤学瘤学.
- 生物统计学 生物统计学
- 医疗信息学 医疗信息学
背景情况:
- 设计用于多种癌症早期检测 (MCED) 试验的癌症查试验是具有挑战性的,因为癌症的自然史未知.
- 开发了一个微模拟模型来评估选试验中的MCED测试性能.
研究的目的:
- 在癌症查试验模拟中预测MCED测试的性能和实用性.
- 评估MCED查对癌症阶段分布和死亡率的潜在影响.
主要方法:
- 一个阶段过渡微模拟模型模拟了23种癌症类型的自然史.
- 模拟试验数据使用监测,流行病学和最终结果 (SEER) 计划数据进行校准.
- 针对年度查轮模拟了基于甲基化的MCED测试 (Galleri).
主要成果:
- 在患病率查轮中,积极的预测值在48%至61%之间.
- 三轮查增加了早期 (I/II) 癌症的检测率9%-14%和降低了第四阶段的发病率37%-46%.
- MCED查显示,有可能显著降低晚期癌症和癌症死亡率.
结论:
- 模拟结果为设计有效的MCED癌症查试验提供了指导.
- 将MCED测试纳入常规查中可能有助于更早地检测癌症,并提高美国的生存率.
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