Colorectal AdenomaNCT07366554
Epigenetic Factors of Colorectal Adenoma in Korean
An observational study of Colorectal Adenoma and Colorectal Cancer Precancerous Lesion, run by Bundang CHA Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer Precancerous Lesion
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2026to 9 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Bundang CHA Hospital
Seongnam-si, Gyeonggi-do, 13496
KIM OneJoong, 01021115353, biblian@chamc.co.kr
About this study
Official title: 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.
Read the 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.
- Keywords
- Colorectal Adenoma, DNA Methylation, Epigenetics, Biomarker discovery, SFRP2, TFPI2, SEPT9, SDC2, qMSP, Korean population, Colorectal cancer prevention, Adenoma-carcinoma sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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, %).
Measured: 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, %).
Measured: 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, %).
Measured: 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, %).
Measured: Baseline (Single Time Point)]
Secondary outcomes (4)
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.
Measured: Baseline (Single Time Point)
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.
Measured: Baseline (Single Time Point)
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.
Measured: Baseline (Single Time Point)
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.
Measured: Baseline (Single Time Point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Feb 2026 (estimated)
- Primary completion9 May 2026 (estimated)
- Study completion9 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KIM OneJoong, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366554
- Sponsor's protocol ID
- CHAMC IRB 2025-05-034-004
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Epigenetic Factors of Colorectal Adenoma in Korean
- ClinicalTrials.gov ID
- NCT07366554
- Acronym / sponsor ID
- CHAMC IRB 2025-05-034-004
- Keywords
- Colorectal Adenoma, DNA Methylation, Epigenetics, Biomarker discovery, SFRP2, TFPI2, SEPT9, SDC2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 9 May 2026 (estimated)
- Study completion
- 9 May 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Adenoma Group | – | –Participants undergoing colonoscopic polypectomy for colorectal adenoma. Adenomatous tissue and adjacent normal mucosa will be collected for methylation and sequencing analysis. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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, %).
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, %).
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, %).
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, %).
4 secondary outcomes
Sensitivity and specificity of methylated SFRP2 for detecting adenoma
Time frame: Baseline (Single Time Point)
Sensitivity and specificity of methylated TFPI2 for detecting adenoma
Time frame: Baseline (Single Time Point)
Sensitivity and specificity of methylated SEPT9 for detecting adenoma
Time frame: Baseline (Single Time Point)
Sensitivity and specificity of methylated SDC2 for detecting adenoma
Time frame: Baseline (Single Time Point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma and Colorectal Cancer Precancerous Lesion, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OneJoong KIM, M.D. (82+010+2111+0415, biblian@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylation index of SFRP2 in colorectal tissue (time frame: Baseline (Single Time Point)]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.