| 标题： | 结直肠癌生物标志物检测临床实践指南 |
| title： | Clinical Practice Guidelines for Colorectal Cancer Biomarker Testing |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 标准指南 |
| classification： | Standard guideline |
| 领域： | 诊断 |
| field： | Diagnosis |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 结直肠癌临床科室医生，包括:肿瘤科医生，外科医生，肛肠科医生 结直肠癌病理科医生，包括:病理诊断医生，分子诊断医生，实验室技术员 |
| Guide users： | Clinical specialists involved in the treatment of colorectal cancer include: oncologists, surgeons, and proctologists. Pathology team members specializing in colorectal cancer include: diagnostic pathologists, molecular diagnostics specialists, and laboratory technicians. |
| 证据分级方法： | 强烈推荐:有力的临床研究(多项严谨的meta分析或大型随机对照研究)证实，且结论不太可能被未来的研究结果推翻 推荐:研究结果明确，但证据主体存在一些不足(如多项小型已发表研究)，结论可能随着证据增多而改变 可考虑:循证医学证据相对不足(仅有临床前试验或少数病例报告)，但专家组意见认为可以接受的 不推荐:因缺乏证据不推荐 |
| Evidence grading method： | Strongly Recommended: Supported by robust clinical research (multiple rigorous meta-analyses or large randomized controlled trials) with conclusions unlikely to be overturned by future studies. Recommended: Clear results but with some limitations in the body of evidence (such as multiple small published studies), where conclusions may change as more evidence accumulates. Consider: Practices or treatments where there is relatively insufficient evidence-based medicine(such as preclinical trials or a few case reports), but expert panels believe they are acceptable due to potential benefits or lack of better alternatives. Do Not Recommend: Practices or treatments that lack sufficient evidence, and therefore are not recommended until more data becomes available. |
| 制定单位： | 国家病理质控中心、中华医学会病理学分会 |
| Formulating unit： | PQCC，Chinses Society of Pathology |
| 注册时间： | 2024-10-17 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN847 |
| Registration number： | |
| 指南制订的目的： | 结直肠癌（colorectal cancer，CRC）是威胁人类健康的主要恶性肿瘤之一。全球癌症统计数据显示 2022 年全球新发癌症1,996 万例，结直肠癌仍是发病率前三的恶性肿瘤疾病。国家癌症中心基于肿瘤登记及随访监测发布了2022年中国恶性肿瘤疾病负担情况，结直肠癌新发癌症病例位于第二，高达51.71万例（男性30.77万例，女性20.94万例），死亡病例为24.00万例。精准医学时代靶向治疗和免疫治疗的出现为结直肠癌患者带来了新的希望，分子标志物检测在临床诊疗中扮演着越来越重要的角色。精准的分子标志物检测是实现结直肠癌精准诊疗的前提，2022年一项全国范围多中心临床流行病学研究显示，我国晚期结直肠癌患者的RAS、BRAF和MSI检测率分别为41.4%、36.1%和28.2%，提示了我国结直肠癌分子标志物检测的规范化开展仍存在很大的提升空间。 继2018年发布《结直肠癌分子生物标志物检测专家共识》之后，中华医学会病理学分会与国家病理质控中心联合成立了结直肠癌分子标志物检测指南制定多学科工作组。工作组依据近年来的循证医学证据及世界卫生组织推荐的指南制定原则和方法，对分子标志物的临床应用、检测方法及质量控制等方面进行了指南的编写工作。本指南旨在为医疗保健专业人员提供关于结直肠癌生物标志物检测的最新科学证据与临床实践建议，以提高诊断准确性、优化治疗决策并最终改善患者的预后。 |
| Purpose of the guideline： | Colorectal cancer (CRC) remains one of the primary malignant tumors threatening human health. According to global cancer statistics, there were 19.96 million new cases of cancer in 2022, with colorectal cancer still ranking among the top three cancers by incidence. The National Cancer Center released data on the burden of malignant tumors in China for 2022, showing that colorectal cancer was the second most common new cancer diagnosis, with as many as 517,100 new cases (307,700 in males and 209,400 in females), and 240,000 deaths. In the era of precision medicine, the emergence of targeted therapy and immunotherapy has brought new hope to patients with colorectal cancer, and molecular marker testing plays an increasingly important role in clinical diagnosis and treatment. Accurate molecular marker testing is a prerequisite for achieving precise diagnosis and treatment of colorectal cancer. A nationwide multi-center clinical epidemiological study conducted in 2022 showed that the detection rates for RAS, BRAF, and MSI among patients with advanced colorectal cancer in our country were 41.4%, 36.1%, and 28.2%, respectively, indicating significant room for improvement in the standardization of colorectal cancer molecular marker testing. Following the publication of the "Expert Consensus on Molecular Biomarker Testing for Colorectal Cancer" in 2018, the Chinese Medical Association's Pathology Branch and the National Pathology Quality Control Center jointly established a multidisciplinary working group to develop guidelines for molecular biomarker testing in colorectal cancer. The working group, based on recent evidence from evidence-based medicine and following the principles and methods recommended by the World Health Organization for guideline development, has been engaged in writing the guidelines covering clinical application, testing methods, and quality control of molecular markers. This guideline aims to provide healthcare professionals with the latest scientific evidence and clinical practice recommendations regarding biomarker testing in colorectal cancer, to enhance diagnostic accuracy, optimize treatment decisions, and ultimately improve patient outcomes. |
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