Epigenetic Factors of Colorectal Adenoma in Korean
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-85
SponsorBundang CHA Hospital
About this trial
This study aims to explore epigenetic factors associated with colorectal adenoma (CRA) in the Korean population. CRA is a key precancerous lesion in the adenoma-carcinoma sequence, and identifying methylated genetic markers may improve early detection and risk stratification for colorectal cancer (CRC).
A total of 32 patients undergoing colonoscopic polypectomy will be enrolled. Adenomatous and adjacent normal tissues will be collected for deoxyribonucleic acid (DNA) extraction and bisulfite conversion. Quantitative methylation-specific polymerase chain reaction (qMSP) and Sanger sequencing will be used to assess the methylation status of candidate genes (SFRP2, TFPI2, SEPT9, and SDC2). Stool samples will also be analyzed by whole-genome sequencing (WGS) to evaluate microbiome and genetic profiles.
The study seeks to determine whether methylation levels of these genes are significantly elevated in adenoma tissue compared with normal mucosa, thereby identifying potential biomarkers for colorectal neoplasia surveillance and personalized colonoscopy follow-up intervals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19-85 years
Undergoing colonoscopic polypectomy for colorectal adenoma
Able to understand the study purpose and provide written informed consent
Adequate tissue available for both adenoma and adjacent normal mucosa sampling
Disqualifiers
History of colorectal cancer, inflammatory bowel disease, or hereditary colorectal cancer syndrome (e.g., FAP, Lynch syndrome)
Previous colorectal surgery that may alter anatomy or pathology
Inadequate sample quality or failure of DNA extraction
Refusal or withdrawal of informed consent
Trial population
Patients undergoing colonoscopic polypectomy for colorectal adenoma at Bundang CHA Hospital. Participants will be enrolled consecutively among those who provide written informed consent for collection of adenomatous and adjacent normal tissues. The study population represents adults aged 19-85 years who are clinically eligible for colonoscopy and tissue sampling
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 1 trial groupGroup A: Colorectal Adenoma Group
Trial outcomes
Primary outcomes
1
Methylation index of SFRP2 in colorectal tissue
Quantitative assessment of DNA methylation levels in adenomatous versus adjacent normal colorectal tissues. Methylation levels will be determined using quantitative methylation-specific PCR (qMSP) and expressed as methylation index (MtI, %).
Time frame
Baseline (Single Time Point)]2
Methylation index of TFPI2 in colorectal tissue
Quantitative assessment of DNA methylation levels in adenomatous versus adjacent normal colorectal tissues. Methylation levels will be determined using quantitative methylation-specific PCR (qMSP) and expressed as methylation index (MtI, %).
Time frame
Baseline (Single Time Point)]3
Methylation index of SEPT9 in colorectal tissue
Quantitative assessment of DNA methylation levels in adenomatous versus adjacent normal colorectal tissues. Methylation levels will be determined using quantitative methylation-specific PCR (qMSP) and expressed as methylation index (MtI, %).
Time frame
Baseline (Single Time Point)]4
Methylation index of SDC2 in colorectal tissue
Quantitative assessment of DNA methylation levels in adenomatous versus adjacent normal colorectal tissues. Methylation levels will be determined using quantitative methylation-specific PCR (qMSP) and expressed as methylation index (MtI, %).
Time frame
Baseline (Single Time Point)]Secondary outcomes
1
Sensitivity and specificity of methylated SFRP2 for detecting adenoma
Receiver operating characteristic (ROC) curve analysis will be used to evaluate the diagnostic performance of methylated SFRP2 in distinguishing adenomatous from normal tissue. The percentage of methylated reference (PMR) values derived from qMSP will be compared between groups.
Time frame
Baseline (Single Time Point)2
Sensitivity and specificity of methylated TFPI2 for detecting adenoma
Receiver operating characteristic (ROC) curve analysis will be used to evaluate the diagnostic performance of methylated TFPI2 in distinguishing adenomatous from normal tissue. The percentage of methylated reference (PMR) values derived from qMSP will be compared between groups.
Time frame
Baseline (Single Time Point)3
Sensitivity and specificity of methylated SEPT9 for detecting adenoma
Receiver operating characteristic (ROC) curve analysis will be used to evaluate the diagnostic performance of methylated SEPT9 in distinguishing adenomatous from normal tissue. The percentage of methylated reference (PMR) values derived from qMSP will be compared between groups.
Time frame
Baseline (Single Time Point)4
Sensitivity and specificity of methylated SDC2 for detecting adenoma
Receiver operating characteristic (ROC) curve analysis will be used to evaluate the diagnostic performance of methylated SDC2 in distinguishing adenomatous from normal tissue. The percentage of methylated reference (PMR) values derived from qMSP will be compared between groups.
Time frame
Baseline (Single Time Point)Sponsors and contacts
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Source ClinicalTrials.gov
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