An Exploratory Study on Gene Methylation Detection of Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorZhejiang Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sample Source: Hospital physical examination, outpatient, and inpatient patients;
Patient Information: Patient information (such as age, hospital ID number, gender, clinical diagnosis, colonoscopy and pathology results) is traceable;
Age Requirement: ≥ 40 years old;
Sampling Time Requirement: Stool and plasma samples must be collected within 3 months prior to colonoscopy (stool samples are preferred).
Disqualifiers
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;
Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
Trial population
Hospital physical examination, outpatient, and inpatient patients;
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
This study does not require intervention trials
Diagnostic testThis study does not require intervention trials
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
human stool gene methylation
The core of the study is to detect the methylation levels of three genes in human stool samples. These three genes are SDC2, COL4A2, and C9orf50. The procedure includes stool sample collection, stool nucleic acid extraction, bisulfite conversion, and detection using the qMSP (quantitative Methylation-Specific PCR) method.
Time frame
2024.12-2025.8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang Provincial People's Hospital
Lead sponsor
Jinjiang Central Hospital
Collaborator
Xilingol League Central Hospital
Collaborator
Zybio Inc.
Collaborator
Haining Central Hospital
Collaborator
Tiantai County People's Hospital
Collaborator
Xianju People's Hospital
Collaborator
Fuyang District People's Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Source ClinicalTrials.gov