NCT07033156

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer（CRC）

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this exploration study is to evaluate the performance of a colorectal cancer (CRC) early screening model based on the DNA methylation technology platform. The study focuses on individuals over the age of 40 and aims to identify and verify methylation biomarkers for colorectal cancer using stool samples . The main question it aims to answer is: Can a DNA methylation-based model effectively detect colorectal cancer and adenoma in individuals over 40 using non-invasive stool samples? Participants will provide stool samples for methylation analysis. The study results will be used solely for internal product performance evaluation and optimization by the sponsor and will not be used for product registration or influence any clinical diagnosis.

Conditions

• CRC (Colorectal Cancer)
• Adenoma Colon

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	This study does not require intervention trials	This study does not require intervention trials

Timeline

• Start date: 2024-12-24
• Primary completion: 2025-08-20
• Completion: 2025-10-20
• First posted: 2025-06-24
• Last updated: 2025-06-29

Locations

1 site across 1 country: China