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.

Abstract

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. 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. 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. ChiCTR2400086754.