An Exploratory Study on Gene Methylation Detection of Colorectal Cancer
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 . Th
| Condition(s) | CRC (Colorectal Cancer), Adenoma Colon |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 40 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Zhejiang Provincial People's Hospital |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-12-24 |
| NCT ID | NCT07033156 |
| Official listing | https://clinicaltrials.gov/study/NCT07033156 |