Epigenetic Factors of Colorectal Adenoma in Korean

January 25, 2026 updated by: KIM OneJoong, Bundang CHA Hospital

Exploration of Epigenetic Factors of Colorectal Adenoma in Korean

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Colorectal cancer (CRC) is one of the most common malignancies in Korea, ranking second in national cancer incidence statistics. Most CRCs arise through the adenoma-carcinoma sequence, in which epigenetic and genetic alterations play critical roles. Identifying methylated genetic markers in colorectal adenoma may provide insights into early carcinogenic mechanisms and enable more individualized surveillance strategies after polypectomy.

This study focuses on exploring epigenetic factors-particularly DNA methylation patterns-associated with colorectal adenoma in Korean patients. A total of 32 participants undergoing colonoscopic polypectomy will be recruited. From each participant, both adenomatous tissue and adjacent normal mucosa (approximately 5 millimeters (mm) in size) will be collected. Stool samples will also be obtained for microbiome and genomic analysis.

DNA extracted from tissue and stool samples will undergo bisulfite conversion using the EZ DNA Methylation-Gold Kit (Zymo Research). Quantitative methylation-specific polymerase chain reaction (qMSP) will be performed to evaluate promoter methylation levels of four candidate genes-SFRP2 (Secreted Frizzled Related Protein 2), TFPI2 (Tissue Factor Pathway Inhibitor 2), SEPT9 (Septin 9), and SDC2 (Syndecan 2)-that have previously shown potential as colorectal neoplasia biomarkers. Selected samples will also undergo Sanger sequencing for CpG-level methylation profiling. Stool DNA will be analyzed through whole-genome sequencing (WGS) on the Illumina NovaSeq 6000 platform to assess microbial composition and genetic context.

Methylation indices (MtI) and percentage of methylated reference (PMR) values will be calculated and compared between adenoma and adjacent normal tissues. Receiver operating characteristic (ROC) curve analysis will determine the sensitivity and specificity of each gene as a potential biomarker.

By identifying methylated genes that are significantly upregulated in adenomatous tissues, this study aims to propose candidate epigenetic markers for predicting the recurrence or malignant transformation of colorectal adenoma. The findings may contribute to refining post-polypectomy surveillance intervals and supporting precision prevention strategies in CRC.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Bundang CHA Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

  • Inclusion Criteria:

    • 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

  • Exclusion Criteria:

    • 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
    • Severe comorbidities that make participation unsuitable at investigator's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Colorectal Adenoma Group
Participants undergoing colonoscopic polypectomy for colorectal adenoma. Adenomatous tissue and adjacent normal mucosa will be collected for methylation and sequencing analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methylation index of SFRP2 in colorectal tissue
Time Frame: Baseline (Single Time Point)]
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, %).
Baseline (Single Time Point)]
Methylation index of TFPI2 in colorectal tissue
Time Frame: Baseline (Single Time Point)]
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, %).
Baseline (Single Time Point)]
Methylation index of SEPT9 in colorectal tissue
Time Frame: Baseline (Single Time Point)]
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, %).
Baseline (Single Time Point)]
Methylation index of SDC2 in colorectal tissue
Time Frame: Baseline (Single Time Point)]
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, %).
Baseline (Single Time Point)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of methylated SFRP2 for detecting adenoma
Time Frame: Baseline (Single Time Point)
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.
Baseline (Single Time Point)
Sensitivity and specificity of methylated TFPI2 for detecting adenoma
Time Frame: Baseline (Single Time Point)
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.
Baseline (Single Time Point)
Sensitivity and specificity of methylated SEPT9 for detecting adenoma
Time Frame: Baseline (Single Time Point)
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.
Baseline (Single Time Point)
Sensitivity and specificity of methylated SDC2 for detecting adenoma
Time Frame: Baseline (Single Time Point)
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.
Baseline (Single Time Point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bundang CHA Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2026

Primary Completion (Estimated)

May 9, 2026

Study Completion (Estimated)

May 9, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHAMC IRB 2025-05-034-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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