Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis.

Methods

In a randomized, controlled trial conducted in England, we obtained peripheral blood from persons 50 to 77 years of age at up to three annual visits.

在英国进行的一项随机对照试验中，我们在最多三次年度访问中从50至77岁的个体中获取外周血。

After baseline blood collection, participants were randomly assigned in a 1:1 ratio to the intervention group (participants whose blood was tested) or the control group (participants whose blood was stored).

在基线血液采集后，参与者以1:1的比例随机分配到干预组（接受血液检测的参与者）或对照组（血液被储存的参与者）。

Participants and trial personnel were initially unaware of the group assignments.

最初，参与者和试验人员并不知道分组情况。

The primary end point was stage III or IV cancer among 12 prespecified types of cancer, and a key secondary end point was stage IV cancer among the 12 prespecified types.

主要终点是12种预设癌症类型中的III期或IV期癌症，一个关键的次要终点是12种预设癌症类型中的IV期癌症。

The differences between the groups in the incidencerate (the number of first eligible events divided by person-years at risk) were measured after three screening rounds and at least 12 months of follow-up after the last participant's third visit.

在三次筛查轮次和最后一次参与者第三次访问后至少12个月的随访期间，测量了两组之间发病率（首次合格事件数除以风险人年数）的差异。

Results

Overall, 71,122 participants were randomly assigned to the intervention group and 71,128 to the control group.

总体而言，71,122名参与者被随机分配到干预组，71,128名被分配到对照组。

The incidencerate of stage III or IV cancer (primary end point) did not differ significantly between the groups (incidencerate ratio [intervention vs. control], 1.03; 95% confidence interval[CI], 0.92 to 1.14, P = 0.63).

III期或IV期癌症（主要终点）的发病率在两组之间没有显著差异（发病率比[干预组对比对照组]，1.03；95%置信区间[CI]，0.92至1.14，P = 0.63）。

The incidencerate ratio for stage IV cancer (a key secondary end point) after 3 screening rounds was 0.86 (95% CI, 0.74 to 1.00).

在进行了3轮筛查后，IV期癌症的发病率比率为0.86（95%置信区间，0.74至1.00）。

Less than 1% of participants had trial-related adverse events; none were serious.

参与者的试验相关不良事件少于1%；没有严重的不良事件。

Conclusions

In this trial, we did not observe a lower incidencerate of stage III or IV cancers across 12 prespecified cancers after three screening rounds with multicancer early-detection testing plus usual care than with usual care alone.

在这项试验中，我们没有观察到在进行了3轮多癌早期检测测试加常规护理后，12种预先指定的癌症中III期或IV期癌症的发生率低于仅使用常规护理的情况。

Further follow-up is warranted to assess the way in which findings for stage III or IV cancers and the between-group difference in stage IV cancers evolve over time.

需要进一步的随访来评估III期或IV期癌症的发现以及IV期癌症组间差异随时间的演变。

(Funded by Grail; NHS-Galleri ClinicalTrials.gov number, NCT05611632; ISRCTN number, ISRCTN91431511.).

该研究由Grail资助；NHS-Galleri临床试验注册号为NCT05611632；ISRCTN编号为ISRCTN91431511。