Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, 1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi 980-8574, Japan.
Jpn J Clin Oncol. 2011 Feb;41(2):275-7. doi: 10.1093/jjco/hyq214. Epub 2010 Dec 2.
In cancer screening, it is essential to undertake effective screening with appropriate methodology, which should be supported by evidence of a reduced mortality rate. At present, mammography is the only method for breast cancer screening with such evidence. However, mammography does not achieve sufficient accuracy in breasts with high density at ages below 50. Although ultrasonography achieves better accuracy in Breast Cancer detection even in dense breasts, the effectiveness has not been verified. We have planned a randomized controlled trial to assess the effectiveness of ultrasonography in women aged 40-49, with a design to study 50,000 women with mammography and ultrasonography (intervention group), and 50,000 controls with mammography only (control group). The participants are scheduled to take second round screening with the same modality 2 years on. The primary endpoints are sensitivity and specificity, and the secondary endpoint is the rate of advanced breast cancers.
在癌症筛查中，采用适当的方法进行有效的筛查至关重要，而这种方法应该有降低死亡率的证据支持。目前，只有乳腺 X 线摄影术是具有这种证据的乳腺癌筛查方法。然而，在年龄低于 50 岁的乳腺密度较高的情况下，乳腺 X 线摄影术并不能达到足够的准确性。虽然超声检查在致密乳腺中的乳腺癌检测中具有更高的准确性，但有效性尚未得到验证。我们计划进行一项随机对照试验，以评估超声检查在 40-49 岁女性中的有效性，设计方案为对 50000 名接受乳腺 X 线摄影术和超声检查的女性（干预组）和 50000 名仅接受乳腺 X 线摄影术的对照者（对照组）进行研究。这些参与者计划在 2 年后接受相同模式的第二轮筛查。主要终点是敏感性和特异性，次要终点是晚期乳腺癌的发生率。
