Epigenetic Factors of Colorectal Adenoma in Korean

NCT07366554 | Not Yet Recruiting

• 1 other identifier: CHAMC IRB 2025-05-034-004
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Adenoma; Colorectal Cancer Precancerous Lesion

Keywords

Colorectal Adenoma; DNA Methylation; Epigenetics; Biomarker discovery; SFRP2; TFPI2; SEPT9; SDC2; qMSP; Korean population; Colorectal cancer prevention; Adenoma-carcinoma sequence

Outcome Measures

Primary Outcomes (4)

• 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, %).

  Baseline (Single Time Point)]

• 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, %).

  Baseline (Single Time Point)]

• 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, %).

  Baseline (Single Time Point)]

• 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, %).

  Baseline (Single Time Point)]

Secondary Outcomes (4)

• Sensitivity and specificity of methylated SFRP2 for detecting adenoma

  Baseline (Single Time Point)

• Sensitivity and specificity of methylated TFPI2 for detecting adenoma

  Baseline (Single Time Point)

• Sensitivity and specificity of methylated SEPT9 for detecting adenoma

  Baseline (Single Time Point)

• Sensitivity and specificity of methylated SDC2 for detecting adenoma

  Baseline (Single Time Point)

Study Arms (1)

Colorectal Adenoma Group

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

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bundang CHA Hospital: lead

Study Sites (1)

Bundang CHA Hospital

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, stool

Central Study Contacts

OneJoong KIM, M.D.

CONTACT

82+010+2111+0415; biblian@chamc.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 26, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)