Stool-based gene methylation test for early colorectal cancer and adenoma detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project collects stool (and optionally plasma) samples from adults aged 40 and above and links them to colonoscopy and pathology results to identify DNA methylation biomarkers for colorectal cancer and adenoma. Samples must be collected within three months prior to colonoscopy and have traceable clinical information. Subjects with a prior history or treatment of colorectal cancer or advanced precancerous lesions are excluded. The data and results will be used internally by the sponsor to optimize product performance and will not be used for regulatory approval or clinical diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: zhenyuan qian
• Email: dr_qianzhenyuan@163.com
• Phone: +86 13858195659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.