Actively Recruiting
An Exploratory Study on Gene Methylation Detection of Colorectal Cancer (CRC)
Led by Zhejiang Provincial People's Hospital ยท Updated on 2025-06-29
450
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Provincial People's Hospital
Lead Sponsor
J
Jinjiang Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new early screening model for colorectal cancer (CRC) using DNA methylation technology. This study focuses on individuals aged 40 and older and aims to identify and verify methylation biomarkers for colorectal cancer and adenoma through non-invasive stool samples. The main question is whether this DNA methylation-based model can effectively detect colorectal cancer and adenoma in this population. Participants will provide stool samples for methylation analysis, with samples collected within three months prior to colonoscopy. The study does not involve any treatment or intervention but focuses on diagnostic testing. The results will be used by the sponsor for internal evaluation and optimization of the screening model and will not influence clinical diagnosis or product registration. During the study, participants' stool and plasma samples will be collected and analyzed for gene methylation from December 2024 to August 2025. Clinical information, including age, hospital ID, gender, colonoscopy, and pathology results, will be tracked. The primary outcome measured is human stool gene methylation. Participation involves providing samples and relevant clinical data, with no treatment or change to usual care required.
CONDITIONS
Brief Title
An Exploratory Study on Gene Methylation Detection of Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sample source includes hospital physical examination, outpatient, and inpatient patients
- Patient information such as age, hospital ID, gender, clinical diagnosis, colonoscopy and pathology results must be traceable
- Age 40 years or older
- Stool and plasma samples must be collected within 3 months prior to colonoscopy, stool samples preferred
You will not qualify if you...
- Unclear sample collection time or stool samples not collected within 3 months prior to colonoscopy
- Samples not meeting collection and storage requirements
- History or treatment of colorectal cancer or advanced precancerous lesions
- Insufficient sample volume for testing
- Diagnosis or family history of hereditary colorectal cancer syndromes including familial adenomatous polyposis, Lynch syndrome, and others
- Diagnosis or personal history of inflammatory bowel disease such as chronic ulcerative colitis or Crohn's disease
- Diagnosis of Cronkhite-Canada syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months prior to colonoscopy
Participants provide stool and plasma samples for gene methylation detection related to colorectal cancer.
1 visit for sample collection
Duration - Approximately 8 months
Participants are observed over time for gene methylation outcomes without active intervention.
No additional visits required
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
zhenyuan qian
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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