Clarke Christina A, Mitchell Breeana L, Alme Emma, Beer Jonathan P, Beer Tomasz M, Beidelschies Michelle A, Hoyos Jody, Klein Eric A, Kuhn Peter, Krunic Nancy, Lang Kathryn, Lee Jerry S H, Lopez Ramos Dorys, Morgenstern David, Putcha Girish, Quinn Elissa, Raymond Victoria M, Rubinstein Wendy S, Sanchez Stephanie A, Serra Ryan W, Stewart Mark D, Leiman Lauren C
GRAIL, Inc., Menlo Park, California.
Natera, Austin, Texas.
Clin Cancer Res. 2025 Jun 13;31(12):2267-2270. doi: 10.1158/1078-0432.CCR-24-4269.
In recent years, there has been a surge in the development of new, blood-based, single- and multi-cancer detection tests (SCD and MCD), which can detect cancer signals prior to the onset of symptoms or clinical diagnosis of cancer. Recognizing the need for consensus definitions and standardized evidence development frameworks for these new types of blood tests, the Early Detection and Screening Working Group of the Blood Profiling Atlas in Cancer Consortium, a collaborative initiative dedicated to advancing standards and best practices, developed and published a lexicon for liquid biopsy-based SCD and MCD tests. During the preparation of the lexicon, the group recognized challenges with regard to the definitions of key terms and concepts describing absolute and RR assessment of intended use populations for cancer screening tests. This article captures the working group's discussions on (i) risk assessment including considerations for adapting historical SCD risk terminology like "average risk" and "elevated risk" to MCD tests, (ii) the implications of this terminology for describing intended use populations, and (iii) the existing gaps in evidence for determination of absolute risks.
近年来，新型血液单癌和多癌检测试验（SCD和MCD）的开发激增，这些检测能够在癌症症状出现或临床诊断之前检测到癌症信号。认识到需要为这些新型血液检测制定共识定义和标准化证据开发框架，癌症联盟血液图谱早期检测与筛查工作组（一项致力于推进标准和最佳实践的合作倡议）制定并发布了基于液体活检的SCD和MCD检测的词汇表。在编写该词汇表期间，该小组认识到在描述癌症筛查试验预期使用人群的绝对风险和相对风险评估的关键术语和概念的定义方面存在挑战。本文记录了工作组关于以下方面的讨论：（i）风险评估，包括将历史SCD风险术语（如“平均风险”和“高风险”）应用于MCD检测的考虑因素；（ii）该术语对描述预期使用人群的影响；（iii）确定绝对风险的现有证据差距。
