Exploratory Study Using DNA Methylation to Detect Colorectal Cancer and Adenoma in Adults Over 40

What this Trial Is About

Researchers are evaluating a new early screening model for colorectal cancer CRC using DNA methylation technology. This study focuses on individuals aged 40 and older and aims to identify and verify methylation biomarkers for colorectal cancer and adenoma through non-invasive stool samples. The main question is whether this DNA methylation-based model can effectively detect colorectal cancer and adenoma in this population. Participants will provide stool samples for methylation analysis, with samples collected within three months prior to colonoscopy. The study does not involve any treatment or intervention but focuses on diagnostic testing. The results will be used by the sponsor for internal evaluation and optimization of the screening model and will not influence clinical diagnosis or product registration. During the study, participants stool and plasma samples will be collected and analyzed for gene methylation from December 2024 to August 2025. Clinical information, including age, hospital ID, gender, colonoscopy, and pathology results, will be tracked. The primary outcome measured is human stool gene methylation. Participation involves providing samples and relevant clinical data, with no treatment or change to usual care required.

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer