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在一家三级转诊中心对无症状患者实施多癌检测(MCD)测试:一项为期18个月的前瞻性队列研究。

Implementation of a Multicancer Detection (MCD) Test in a Tertiary Referral Center in Asymptomatic Patients: An 18-Month Prospective Cohort Study.

作者信息

Hurt Ryan T, Ghosh Aditya K, Dougan Brian M, Gilman Elizabeth A, Salonen Bradley R, Adusumalli Jay, Bonnes Sara L, Andersen Carl A, Pasha Amirala S, Nanda Sanjeev, Pagel Erin M, Verness Christina D, Crowley Steven D, Ressler Steven W, Samadder Jewel J, Presutti Richard J, Chaudhuri Aadel A, Sanchez William, Croghan Ivana T, Stephenson Christopher R, Ghosh Karthik

机构信息

Mayo Clinic, Rochester, MN, USA.

Mayo Clinic, Scottsdale, AZ, USA.

出版信息

J Prim Care Community Health. 2025 Jan-Dec;16:21501319251329290. doi: 10.1177/21501319251329290. Epub 2025 Mar 25.

DOI:10.1177/21501319251329290
PMID:40132152
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11938867/
Abstract

OBJECTIVE

Multicancer Detection (MCD) tests, such as the GRAIL Galleri, offer a novel approach to cancer screening by detecting cancer-specific methylation patterns in cell-free DNA through a single blood sample. This study evaluated an 18-month implementation of MCD testing in a tertiary ambulatory internal medicine clinic.

PATIENTS AND METHODS

Between June 2022 and November 2023, 2244 asymptomatic (without symptoms attributed to cancer) patients underwent MCD testing. The study focused on operational workflows, patient and physician education, and diagnostic follow-up of positive results. Standardized materials, including electronic health record (EHR) workflows, FAQs, and diagnostic pathways, were developed to facilitate implementation. Challenges included managing false positives, patient anxiety, costs, and ethical considerations.

RESULTS

Of the 2244 patients tested, 17 (0.76%) had positive results, and 15 underwent further diagnostic evaluation. Cancer was confirmed in 11 (73.3%) patients, including cases of breast, colon, esophageal, lymphoma, ovarian, and pancreatic cancers. Four patients had no identifiable malignancy despite comprehensive work-up.

CONCLUSIONS

MCD testing is feasible in routine clinical workflows, with 73% of positive cases yielding cancer diagnoses. While promising, further research is required to assess long-term outcomes, cost-effectiveness, and optimal implementation strategies of cancer interception in broader healthcare settings.

摘要

目的

多癌检测(MCD)测试,如GRAIL Galleri测试,通过检测游离DNA中癌症特异性甲基化模式,利用单一血样为癌症筛查提供了一种新方法。本研究评估了在一家三级门诊内科诊所实施18个月的MCD测试情况。

患者与方法

在2022年6月至2023年11月期间,2244名无症状(无归因于癌症的症状)患者接受了MCD测试。该研究聚焦于操作流程、患者及医生教育以及阳性结果的诊断随访。开发了标准化材料,包括电子健康记录(EHR)工作流程、常见问题解答和诊断路径,以促进实施。挑战包括处理假阳性、患者焦虑、成本和伦理考量。

结果

在接受测试的2244名患者中,17名(0.76%)结果呈阳性,15名接受了进一步的诊断评估。11名(73.3%)患者确诊患有癌症,包括乳腺癌、结肠癌、食管癌、淋巴瘤、卵巢癌和胰腺癌。尽管进行了全面检查,仍有4名患者未发现恶性肿瘤。

结论

MCD测试在常规临床工作流程中是可行的,73%的阳性病例确诊为癌症。虽然前景广阔,但需要进一步研究以评估更广泛医疗环境中癌症拦截的长期结果、成本效益和最佳实施策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/8d238c0dbfc2/10.1177_21501319251329290-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/7aa46f18980a/10.1177_21501319251329290-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/b9d8b5fcaf56/10.1177_21501319251329290-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/3d72b0456b0b/10.1177_21501319251329290-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/6cb8a9aab0df/10.1177_21501319251329290-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/8d238c0dbfc2/10.1177_21501319251329290-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/7aa46f18980a/10.1177_21501319251329290-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/b9d8b5fcaf56/10.1177_21501319251329290-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/3d72b0456b0b/10.1177_21501319251329290-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/6cb8a9aab0df/10.1177_21501319251329290-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b65/11938867/8d238c0dbfc2/10.1177_21501319251329290-fig5.jpg

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本文引用的文献

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Barriers and proposed solutions to at-home colorectal cancer screening tests in medically underserved health centers across three US regions to inform a randomized trial.
在美国三个地区的医疗服务不足的健康中心进行家庭结直肠癌筛查检测的障碍和建议解决方案,为一项随机试验提供信息。
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