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NCT07033156Recruiting

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

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

Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
450 (estimated)
First submitted
13 Jun 2025
Start date
Dec 2024
Primary completion date
Aug 2025
Lead sponsor
Zhejiang Provincial People's Hospital
NCT number
NCT07033156

What you commit to

  • Study type: Observational
  • Planned participants: 450
  • From Dec 2024 to the primary completion date, Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
  • 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.

Other

  • Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
  • Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;

Who the study is looking for

  • 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).

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Provincial People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.