Clinical Trial

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

Recruiting
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Record status
This record was last updated June 29, 2025 (before its estimated August 20, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-13.
Trial Details
NCT Number NCT07033156
Lead Sponsor Zhejiang Provincial People's Hospital
Collaborators: Jinjiang Central Hospital, Xilingol League Central Hospital, Zybio Inc., Haining Central Hospital, Tiantai County People's Hospital, Xianju People's Hospital, Fuyang District People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions CRC (Colorectal Cancer), Adenoma Colon
Enrollment 450 participants
Start Date 2024-12-24
Primary Completion 2025-08-20 (estimated)
Study Completion 2025-10-20 (estimated)
Updated on ClinicalTrials.gov 2025-06-29