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

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

This project will try a stool-based DNA methylation test to see if it can detect colorectal cancer and adenomas in people aged 40 and older.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07033156 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 40 or older who can provide stool (preferably) or plasma samples collected within three months before a colonoscopy and whose clinical and pathology records are traceable, with no prior CRC or advanced precancerous lesion history.

Not a fit: People under 40, those with a history or treatment of colorectal cancer or advanced precancerous lesions, or those unable to provide timely, traceable stool samples are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a non‑invasive stool test that helps detect colorectal cancer and precancerous adenomas earlier, potentially reducing reliance on invasive procedures.

How similar studies have performed: Similar stool DNA methylation and multitarget stool DNA approaches have shown promise and some are used clinically, though the specific biomarkers in this project may be novel and require validation.

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: zhenyuan qian

Conditions CRC; Adenoma Colon