Exploration of Epigenetic Factors of Colorectal Adenoma in Korean
Conditions: Colorectal Adenoma, Colorectal Cancer Precancerous Lesion
Sponsor: Bundang CHA Hospital

Study Protocol 
Official Title: Exploration of Epigenetic Factors of Colorectal Adenoma in Korean 
Short Title: Epigenetic Biomarker Study for Colorectal Adenoma 
Version: 3.0 
Document Date: 2025-7-2 
Principal Investigator: OneJoong KIM, M.D. 
Department of Gastroenterology, CHA Bundang Medical Center, CHA University, Seongnam, 
Republic of Korea 
Participating Institutions: 
• CHA Bundang Medical Center (Seongnam, Korea) 
• Eulji University, Department of Clinical Laboratory Science (Uijeongbu, Korea) 
IRB Approval: Reviewed and approved by the Ministry of Health and Welfare–Designated 
Central Institutional Review Board for Human Biological Research. 
ClinicalTrials.gov Identifier (NCT Number): [To be assigned] 
 
 

1. Study Summary 
This observational study explores epigenetic factors associated with colorectal adenoma in 
Korean adults undergoing colonoscopic polypectomy. The study aims to identify DNA 
methylation-based biomarkers that may predict colorectal cancer progression. 
2. Methods 
A total of 32 participants will be enrolled. Adenomatous and adjacent normal colorectal 
tissues will be collected during colonoscopic polypectomy. Stool samples will also be 
obtained for microbiome analysis. DNA will be extracted using Qiagen kits, followed by 
bisulfite conversion and quantitative methylation-specific PCR (qMSP) targeting SFRP2, 
TFPI2, SEPT9, and SDC2. 
3. Statistical Analysis Plan 
Methylation Index (MtI) and Percentage of Methylated Reference (PMR) will be calculated 
using the ΔΔCt method. ROC curve analysis will determine diagnostic accuracy (AUC, 
sensitivity, specificity). Correlations with clinical parameters such as age, BMI, smoking, and 
diet will be assessed. 
4. Ethical Considerations 
All participants will provide written informed consent before inclusion. Personal identifiers 
will be replaced with coded numbers to ensure confidentiality. Biospecimens will be stored 
at −80°C and discarded after analysis. 
5. References 
1. Korea Central Cancer Registry. 2021 Annual Report of Cancer Statistics in Korea. National 
Cancer Center, Ministry of Health and Welfare; 2023. 
2. Oh T, et al. Genome-Wide Identification and Validation of a Novel Methylation Biomarker, 
SDC2, for Blood-Based Detection of Colorectal Cancer. J Mol Diagn. 2013;15(4):498–507. 
3. Park SK, Baek HL, Yu J, et al. Is methylation analysis of SFRP2, TFPI2, NDRG4, and BMP3 
promoters suitable for colorectal cancer screening in the Korean population? Intest Res. 
2017;15(4):495–501. 

Participant Information Sheet and Informed Consent Form 
Official Title: Exploration of Epigenetic Factors of Colorectal Adenoma in Korean 
Short Title: Epigenetic Biomarker Study for Colorectal Adenoma 
Document Type: Participant Information Sheet and Informed Consent Form 
Version: 2.1 (July 10, 2025) 
Principal Investigator: KIM OneJoong, M.D. 
Institution: CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea 
IRB Approval: Ministry of Health and Welfare–Designated Central Institutional Review 
Board for Human Biological Research 
ClinicalTrials.gov Identifier (NCT Number): [To be assigned] 
Document Language: English translation of the original Korean IRB-approved version 
 
 

1. Purpose of the Study 
This study aims to identify methylated genetic factors that may serve as epigenetic markers 
associated with colorectal adenoma in Korean patients. By comparing the methylation 
status of specific genes between adenomatous tissue and adjacent normal mucosa, the study 
seeks to provide evidence for improving post-polypectomy surveillance intervals and 
colorectal cancer prevention strategies. 
2. Participation Period, Procedures, and Methods 
The total study period is expected to run until May 2027. Each participant will be involved 
for approximately one month. Participants undergoing colonoscopic polypectomy will have 
both adenomatous tissue and adjacent normal colorectal tissue (5 mm each) collected 
during the procedure. This additional normal tissue sampling is not part of standard 
treatment but poses minimal risk and no additional cost to participants. Stool samples will 
also be collected using a sterile stool collection kit provided at the outpatient clinic and 
delivered to the laboratory during the hospital visit. Samples will be rapidly frozen in liquid 
nitrogen and transported to the Eulji University Graduate Laboratory (Uijeongbu) for 
analysis. No medications or treatments outside of standard care will be administered, and 
participation will not affect regular medical care. 
3. Number of Participants 
A total of 32 participants, including a 20% expected dropout rate, will be enrolled. 
4. Risks and Benefits 
No drugs or additional tests beyond standard medical care will be performed. There are no 
direct personal benefits or compensations for participation. However, the study may 
provide social benefits by contributing to better understanding of methylation-based 
biomarkers and improving recommendations for follow-up colonoscopy intervals in 
patients with colorectal adenoma. 
5. Compensation for Research-Related Injury 
Polypectomy is a standard treatment for colorectal adenoma; therefore, there is no specific 
compensation for research participation. In case of any adverse event, emergency medical 
care will be provided according to standard hospital procedures. 
6. Withdrawal of Consent 
Participation in this study is entirely voluntary. Participants may withdraw consent at any 
time without penalty or loss of benefits to which they are otherwise entitled. Withdrawal 
will not affect ongoing clinical care or treatment decisions. 
7. Contact for Questions or Concerns 
For any questions about the study, risks, or research-related injuries, please contact: 
Principal Investigator: Dr. Won Joong Kim (CHA Bundang Medical Center) – Tel: +82-31-
780-5000 
Co-Investigator: Prof. Seong Hee Hyun (Eulji University) – Tel: +82-31-951-3000 

 
For questions about your rights as a research participant, contact the CHA IRB Office: +82-
31-780-5302/5314. 
8. Retention and Use of Personal Information 
Personal information will be retained for up to 3 years after study completion, in 
accordance with the Bioethics and Safety Act. After the retention period, all data will be 
permanently destroyed in compliance with the Personal Information Protection Act. 
9. Protection of Confidentiality 
All personal data will be coded with participant identification numbers and initials. Names 
and addresses will be removed from study records. Only authorized research staff will have 
access to identifiable information. No information identifying participants will be disclosed 
in publications or presentations. 
10. Personal and Sensitive Information Handling 
Collected information includes participant ID, sex, date of birth, medical history, clinical 
findings, and genetic analysis results. Sensitive data such as health status or past medical 
history will be handled under strict confidentiality and used only for this study. Participants 
may refuse to provide personal information; however, doing so may preclude study 
participation. 
11. Handling and Disposal of Biospecimens 
Collected biospecimens will be processed according to institutional and legal standards. 
After data acquisition, specimens will be destroyed immediately. If a participant withdraws 
consent before anonymization, the corresponding specimens will be destroyed upon 
request. 
12. Consent Statement 
I have been fully informed about the nature, purpose, risks, and benefits of this study. I 
voluntarily agree to participate in this research and understand that I may withdraw at any 
time without penalty. I have received a copy of this consent form. 
 
Participant Name: ____________________________   Signature: ____________________________   Date: 
____________________________ 
Legal Representative (if applicable): ____________________________   Signature: 
____________________________   Date: ____________________________ 
Investigator Signature: ____________________________   Date: ____________________________