Colorectal cancer screening using a multi-locus blood-based assay targeting circulating tumor DNA methylation: a cross-sectional study in an average-risk population.

IF 7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Baohua Wang, Yunzhi Zhang, Jun Liu, Bin Deng, Qing Li, Hongmei Liu, Yi Sui, Ning Wang, Qin Xiao, Wei Liu, Yan Chen, Yongsheng Li, Haipeng Jia, Qilong Yuan, Cuiping Wang, Wenjun Pan, Fan Li, Huimin Yang, Yongfeng Wang, Yanbing Ding, Daoliang Xu, Rui Liu, Jing-Yuan Fang, Jing Wu
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引用次数: 0

Abstract

Background: Effective screening for colorectal cancer (CRC) enables earlier diagnosis and intervention to improve patient survival.

Methods: In this study, we prospectively conducted a blood-based CRC screening program for community residents in Hanjiang District, Yangzhou City, and evaluated the screening efficacy of a blood-based multi-locus DNA methylation assay (ColonAiQ). The ColonAiQ-positive rate and colonoscopy participation rate of the population, detection rate of intestinal lesions, and positive predictive value (PPV) of CRC and advanced adenoma (AA) were calculated, and the associated factors were explored.

Results: A total of 105,285 participants were enrolled from January 2021 to December 2022, all of whom completed the ColonAiQ assay, yielding a positive rate of 6.42% (6759/105,285). The colonoscopy compliance rate was 48.56% (3282/6759). Intestinal lesions were detected in 1773 individuals (54.02%), including 63 cases of CRCs (predominately early-stage), 1195 adenomas (441 cases of AAs), 327 polyps, and 188 other benign lesions. CRC patients exhibited higher ColonAiQ scores and more positive loci compared to healthy individuals. The PPVs were 1.92% for CRC and 13.44% for AA. Among participants, 66,121 (62.8%) completed questionnaires graded by the Asia-Pacific Colorectal Screening score, with 12,139 (18.36%) classified in the high-risk tier. High-risk participants had a higher ColonAiQ-positive rate (11.07%) and PPVs for CRC (3.46%) and AA (22.18%). Factors associated with increased detection rates for CRC and AA included male gender, older age, a history of alcohol consumption, and prior polyps.

Conclusions: Our study demonstrated that ColonAiQ assay effectively identifies high-risk population. These findings strongly suggest that the ColonAiQ assay represents a promising strategy for the early detection of CRC and AA in individuals at average risk.

Trial registration: Registered at ClinicalTrials.gov (NCT05336539).

使用针对循环肿瘤 DNA 甲基化的基于血液的多焦点检测法筛查结直肠癌:一项针对平均风险人群的横断面研究。
背景:有效的结直肠癌(CRC)筛查可尽早诊断和干预,提高患者生存率:有效的结直肠癌(CRC)筛查可以早期诊断和干预,从而提高患者的生存率:本研究前瞻性地在扬州市涵江区社区居民中开展了基于血液的 CRC 筛查项目,并评估了基于血液的多焦点 DNA 甲基化检测(ColonAiQ)的筛查效果。计算了人群的ColonAiQ阳性率和结肠镜检查参与率、肠道病变检出率、CRC和晚期腺瘤(AA)的阳性预测值(PPV),并探讨了相关因素:2021年1月至2022年12月期间,共有105285名参与者完成了ColonAiQ检测,阳性率为6.42%(6759/105285)。结肠镜检查符合率为 48.56%(3282/6759)。在 1773 人(54.02%)中发现了肠道病变,包括 63 例 CRC(主要是早期)、1195 例腺瘤(441 例 AA)、327 例息肉和 188 例其他良性病变。与健康人相比,CRC 患者的 ColonAiQ 得分更高,阳性位点更多。CRC的PPV为1.92%,AA的PPV为13.44%。在参与者中,有 66121 人(62.8%)完成了根据亚太地区结直肠筛查评分进行分级的问卷调查,其中有 12139 人(18.36%)被归类为高危人群。高风险参与者的 ColonAiQ 阳性率(11.07%)较高,CRC(3.46%)和 AA(22.18%)的 PPV 值也较高。与 CRC 和 AA 检出率增加相关的因素包括男性性别、年龄、饮酒史和既往息肉:我们的研究表明,ColonAiQ 检测能有效识别高危人群。这些研究结果有力地表明,ColonAiQ 检测法是早期检测平均风险人群中的 CRC 和 AA 的有效策略:注册于 ClinicalTrials.gov (NCT05336539)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Medicine
BMC Medicine 医学-医学:内科
CiteScore
13.10
自引率
1.10%
发文量
435
审稿时长
4-8 weeks
期刊介绍: BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
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