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NCT Number: NCT07033156

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

zhenyuan qian

CONTACT

[email protected]

+86 13858195659

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sample Source: Hospital physical examination, outpatient, and inpatient patients;
  • Patient Information: Patient information (such as age, hospital ID number, gender, clinical diagnosis, colonoscopy and pathology results) is traceable;
  • Age Requirement: ≥ 40 years old;
  • Sampling Time Requirement: Stool and plasma samples must be collected within 3 months prior to colonoscopy (stool samples are preferred).

Exclusion criteria

  • Unclear Sample Collection Information: Samples with unclear collection time, or stool samples not collected within 3 months prior to colonoscopy, or samples with incomplete clinical information that cannot be traced;
  • Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
  • History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
  • Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
  • Hereditary Diseases: Subjects with a diagnosis or family history of the following diseases:Familial adenomatous polyposis (FAP), including attenuated FAP and Gardner syndrome;Hereditary nonpolyposis colorectal cancer syndrome (HNPCC or Lynch syndrome);Other hereditary cancer syndromes, including but not limited to Peutz-Jeghers syndrome, MYH-associated polyposis (MAP), Turcot syndrome (or Crail syndrome), Cowden syndrome, juvenile polyposis, neurofibromatosis, or familial proliferative polyposis (FAP);
  • Inflammatory Bowel Disease (IBD): Subjects with a diagnosis or personal history of IBD, including chronic ulcerative colitis and/or Crohn's disease;
  • Cronkhite-Canada Syndrome: Subjects with a diagnosis of Cronkhite-Canada syndrome.

Treatment and study plan

This study does not require intervention trials

Diagnostic Test

This study does not require intervention trials

Primary outcomes

  1. human stool gene methylation

    Time frame: 2024.12-2025.8

    The core of the study is to detect the methylation levels of three genes in human stool samples. These three genes are SDC2, COL4A2, and C9orf50. The procedure includes stool sample collection, stool nucleic acid extraction, bisulfite conversion, and detection using the qMSP (quantitative Methylation-Specific PCR) method.

Study contacts

Contact information is provided by the study sponsor or research team.

zhenyuan qian

CONTACT

[email protected]

+86 13858195659

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Collaborators

  • Fuyang District People's Hospital
  • Haining Central Hospital
  • Jinjiang Central Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Tiantai County People's Hospital
  • Xianju People's Hospital
  • Xilingol League Central Hospital
  • Zybio Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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