使用智能工具（INTEL-PATH CRC）进行结直肠癌筛查的新方法评估：一项多中心、真实世界队列研究方案
Evaluation of a novel approach for colorectal cancer screening using an intelligent tool (INTEL-PATH CRC): a protocol for a multicentre, real-world, cohort study.
作者信息
Yan Yike, Luo Chenyu, Chen Yuqing, Cheng Xinran, Luo Jiahui, Zhou Yueyang, Li Na, Zhang Yuelun, Lu Bin, He Zhiliang, Song Kai, Wu Dong, Chen Hongda, Dai Min
机构信息
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Center for Prevention and Early Intervention, National Infrastructures for Translational Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
出版信息
BMJ Open. 2025 Jul 18;15(7):e098679. doi: 10.1136/bmjopen-2024-098679.
INTRODUCTION
Traditional colorectal cancer (CRC) screening programmes in China face two major challenges: low screening coverage and poor adherence. Mobile health shows promise for cancer prevention, and a WeChat-based intelligent tool has been developed to support full-cycle CRC screening, including risk assessment, individualised screening recommendation, appointment management, result processing and health education. This study aims to evaluate the feasibility and effectiveness of this tool-based screening strategy in a multicentre, prospective cohort.
METHODS AND ANALYSIS
10 000 eligible participants aged 45-74 years will be enrolled from five provinces in China. After signing informed consent, participants need to complete an online questionnaire based on the modified and widely validated Asia-Pacific Colorectal Screening score. A score of ≥4 indicates high risk; otherwise, participants are classified as low or intermediate risk. For high-risk individuals, colonoscopy is recommended as the primary screening method, with faecal immunochemical test (FIT) as an alternative. For those at low or intermediate risk, FIT is recommended, followed by diagnostic colonoscopy for those who test positive. The primary outcomes are the detection rate of advanced colorectal neoplasia, compliance rates and detection rate of any colorectal adenoma at baseline screening. Final diagnoses are based on colonoscopy and pathology results. The secondary outcomes include CRC incidence and mortality, which will be assessed through passive follow-up over at least 10 years using linkage to cancer registry and death surveillance databases.
ETHICS AND DISSEMINATION
The programme was approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College (23/220-3962). Expected outcomes will be disseminated through research reports, peer-reviewed papers, conference and patents.
TRIAL REGISTRATION NUMBER
ChiCTR2400086754.
引言
中国传统的结直肠癌（CRC）筛查项目面临两大挑战：筛查覆盖率低和依从性差。移动健康在癌症预防方面显示出前景，并且已经开发了一种基于微信的智能工具来支持全周期CRC筛查，包括风险评估、个性化筛查建议、预约管理、结果处理和健康教育。本研究旨在评估这种基于工具的筛查策略在多中心前瞻性队列中的可行性和有效性。
方法与分析
将从中国五个省份招募10000名年龄在45 - 74岁的符合条件的参与者。签署知情同意书后，参与者需要根据经过修改且广泛验证的亚太结直肠癌筛查评分完成一份在线问卷。评分≥4表明为高风险；否则，参与者被分类为低风险或中风险。对于高风险个体，推荐结肠镜检查作为主要筛查方法，粪便免疫化学试验（FIT）作为替代方法。对于低风险或中风险个体，推荐FIT，检测结果呈阳性者随后进行诊断性结肠镜检查。主要结局是基线筛查时晚期结直肠肿瘤的检出率、依从率和任何结直肠腺瘤的检出率。最终诊断基于结肠镜检查和病理结果。次要结局包括CRC发病率和死亡率，将通过与癌症登记和死亡监测数据库的关联，对至少10年的被动随访进行评估。
伦理与传播
该项目已获得中国医学科学院肿瘤医院/国家癌症中心、北京协和医学院伦理委员会批准（23/220 - 3962）。预期结果将通过研究报告、同行评审论文、会议和专利进行传播。
试验注册号
ChiCTR2400086754。
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