An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

Launched by ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect colorectal cancer and precancerous growths called adenomas using a simple stool test. The test looks for specific changes in DNA, known as methylation, which can be signs of cancer. The goal is to see if this non-invasive stool test can effectively identify these conditions in people over 40 years old, helping with early detection without needing more invasive procedures right away.

People eligible for this study are adults aged 40 or older who have had a recent colonoscopy and can provide stool samples collected within three months before that procedure. Participants will be asked to provide stool samples, which will be analyzed for these DNA changes. It’s important to note that this study is for research only—the results won’t be used for medical diagnosis or treatment decisions. Also, people with a history of colorectal cancer, certain inherited cancer syndromes, or inflammatory bowel diseases are not eligible to participate. This study is currently recruiting participants, and it aims to improve early screening methods to catch colorectal cancer sooner and more easily.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sample Source: Hospital physical examination, outpatient, and inpatient patients;
• • 2. Patient Information: Patient information (such as age, hospital ID number, gender, clinical diagnosis, colonoscopy and pathology results) is traceable;
• • 3. Age Requirement: ≥ 40 years old;
• • 4. Sampling Time Requirement: Stool and plasma samples must be collected within 3 months prior to colonoscopy (stool samples are preferred).
• Exclusion Criteria:
• • 1. 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;
• • 2. Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
• • 3. History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
• • 4. Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
• • 5. 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);
• • 6. Inflammatory Bowel Disease (IBD): Subjects with a diagnosis or personal history of IBD, including chronic ulcerative colitis and/or Crohn's disease;
• • 7. Cronkhite-Canada Syndrome: Subjects with a diagnosis of Cronkhite-Canada syndrome.