An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

NCT07033156 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-06-29

No results posted yet for this study

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

DIAGNOSTIC_TEST

This study does not require intervention trials

This study does not require intervention trials

Sponsors & Collaborators

  • Jinjiang Central Hospital

    collaborator UNKNOWN
  • Xilingol League Central Hospital

    collaborator UNKNOWN
  • Zybio Inc.

    collaborator UNKNOWN
  • Haining Central Hospital

    collaborator UNKNOWN
  • Tiantai County People's Hospital

    collaborator UNKNOWN
  • Xianju County People's Hospital

    collaborator UNKNOWN
  • Fuyang District People's Hospital

    collaborator UNKNOWN
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Zhejiang Provincial People's Hospital

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2025-08-20
Completion
2025-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033156 on ClinicalTrials.gov