Actively Recruiting

Age: 40Years +
All Genders
Healthy Volunteers
NCT07033156

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

Led by Zhejiang Provincial People's Hospital · Updated on 2025-06-29

450

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang Provincial People's Hospital

Lead Sponsor

J

Jinjiang Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Sample source includes hospital physical examination, outpatient, and inpatient patients
  • Patient information such as age, hospital ID, gender, clinical diagnosis, colonoscopy, and pathology results must be traceable
  • Participants must be 40 years old or older
  • Stool and plasma samples must be collected within 3 months prior to colonoscopy, with stool samples preferred
Not Eligible

You will not qualify if you...

  • Samples with unclear collection time or stool samples not collected within 3 months prior to colonoscopy
  • Samples that do not meet collection and storage requirements
  • History or treatment of colorectal cancer or advanced precancerous lesions
  • Samples with insufficient volume for testing
  • Diagnosis or family history of hereditary colorectal cancer syndromes such as familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, MYH-associated polyposis, Turcot syndrome, Cowden syndrome, juvenile polyposis, neurofibromatosis, or familial proliferative polyposis
  • Diagnosis or personal history of inflammatory bowel disease including chronic ulcerative colitis or Crohn's disease
  • Diagnosis of Cronkhite-Canada syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

Z

zhenyuan qian

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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