斯德哥尔摩3在前列腺癌检测多民族队列 (SEPTA):一个潜在的多中心试验
Hari T Vigneswaran1,2, Martin Eklund1, Andrea Discacciati1
1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
概括
斯德哥尔摩3测试可以通过显著减少不同人群中不必要的活检来改善前列腺癌的检测,同时保持对临床显著前列腺癌 (csPC) 的高灵敏度. 这种生物标志物比单独的PSA提供了更好的特异性.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 在瘤学瘤学.
- 生物标志物发现发现
背景情况:
- 前列腺癌 (PCa) 不成比例地影响亚洲,黑人和西班牙裔男性,这些男性在临床试验中通常代表性不足.
- 在不同患者群体中对新型PCa生物标志物的有限验证阻碍了诊断的公平进展.
研究的目的:
- 评估斯德哥尔摩3风险评分在改善前列腺癌检测在多样化的患者群体中的有效性.
- 评估Stockholm3是否为检测临床显著PCa (csPC) 与前列腺特异性抗原 (PSA) 相比提供非较低的灵敏度和更高的特异性.
主要方法:
- 一项观察性,前性,多中心临床试验,涉及2,129名疑似患有PCa的男性,他们接受了前列腺活检.
- 在活检前测量了斯德哥尔摩3风险评分,包括PSA,kallikrein,GDF15,PSP94,遗传风险和临床因素.
- 主要终点集中在检测ISUP等级≥2癌症 (csPC) 的非劣质敏感性和优异特异性.
主要成果:
- 斯德哥尔摩3表现出与PSA (PSA ≥4 ng/mL) 相比,用于检测csPC的非劣质灵敏度 (0.95) 和近三倍高的特异性 (2.91).
- 这些发现在种族和族裔子组之间是一致的,显示非劣质敏感性 (0.91-0.98) 和优异特异性 (2.51-4.70).
- 使用斯德哥尔摩3可以减少不必要的良性或低等级 (ISUP 1) 前列腺活检总体45%和42-52%在不同的种族和民族群体.
结论:
- 斯德哥尔摩3风险评分有效地减少了不同人群中不必要的前列腺活检.
- 斯德哥尔摩3在检测csPC时对PSA保持了可比的灵敏度,同时显著提高了特异性.
- 这种生物标志物有望在不同患者群体中更准确,更有效地诊断前列腺癌.
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