Colorectal CancerNCT05638542
Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- How many people
- 582 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2015to Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visited Seoul National University Bundang Hospital for gastrointestinal symptomes or regular check-ups, and agreed to participate.
Who may be able to join
- Control group: subjects with no evidence of colorectal adenoma or colorectal cancer
- Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.
- Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma
Who cannot join
- Subjects age under 18 years
- Previous history of colorectal neoplasms
- Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents
- Denial to participate in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.
Read the detailed description
The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Carcinogenesis, Sex difference, Tumor location
- Medical subject headings
- Colorectal Neoplasms, Carcinogenesis
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 |
|---|---|---|
| Control group | Patients who are not diagnosed with colorectal adenoma or colorectal cancer | |
| Colorectal adenoma group | Patients who are diagnosed with colorectal adenoma | |
| Colorectal cancer group | Patients who are diagnosed with colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC
Using endoscopically biopsied specimens, multiple carcinogenic markers were investigated including KRAS and BRAF mutation, PD-L1, EGFR, IL-1b, NLRP3, Caspase-1, p53 expression, Microinstability (MSS, MSI-L, MSI-H), PD-L1, DNA mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), CIMP markers (p16, MINT1, MINT2, MINT31, hMLH1), promoter methylation of p16, RUNX3, NEUROG1.
CIMP was assessed by methylation-specific PCR for five methylation panel markers (p16, MINT1, MINT2, MINT31, hMLH1), and MSI status was validated by PCR using five NCI markers (BAT-26, BAT-25, D5S346, D17S250, and S2S123). KRAS and BRAF mutation was analyzed by direct sequencing using sequence-specific primers from the acquired biopsy specimens. PD-L1, EGFR, MMR expression was examined using immunohistochemistry.
Measured: through study completion, an average of 1 year
Fecal microbiota analysis in patients with colorectal adenoma and CRC
Using next-generation sequencing technique, fecal microbiota of patients with colorectal adenoma and CRC as well as healthy control was evaluated to verify carcinogenesis-related microbiota.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Mar 2015
- Primary completion30 Jan 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph.D, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638542
- Sponsor's protocol ID
- B-1305-203-009
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi Y, Kim N, Song CH, Oh HJ. Sex Hormone Receptor Profiling Reveals an Association between Estrogen Receptor beta-NRF2 Signaling and Improved Outcomes in Colorectal Cancer Patients. Gut Liver. 2026 Jul 24. doi: 10.5009/gnl250538. Online ahead of print.
PubMed 42494363Choi J, Kim N, Nam RH, Kim JW, Song CH, Na HY, Kang GH. Influence of location-dependent sex difference on PD-L1, MMR/MSI, and EGFR in colorectal carcinogenesis. PLoS One. 2023 Feb 21;18(2):e0282017. doi: 10.1371/journal.pone.0282017. eCollection 2023.
PubMed 36802389
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
- ClinicalTrials.gov ID
- NCT05638542
- Acronym / sponsor ID
- B-1305-203-009
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Carcinogenesis, Sex difference, Tumor location
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Dec 2022 (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.
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.
Detailed description
The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients who are not diagnosed with colorectal adenoma or colorectal cancer |
| Colorectal adenoma group | – | –Patients who are diagnosed with colorectal adenoma |
| Colorectal cancer group | – | –Patients who are diagnosed with colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited Seoul National University Bundang Hospital for gastrointestinal symptomes or regular check-ups, and agreed to participate.
Key inclusion criteria (3 listed)
- Control group: subjects with no evidence of colorectal adenoma or colorectal cancer
- Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.
- Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma
Key exclusion criteria (4 listed)
- Subjects age under 18 years
- Previous history of colorectal neoplasms
- Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents
- Denial to participate in this study
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
The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC
Time frame: through study completion, an average of 1 year
Using endoscopically biopsied specimens, multiple carcinogenic markers were investigated including KRAS and BRAF mutation, PD-L1, EGFR, IL-1b, NLRP3, Caspase-1, p53 expression, Microinstability (MSS, MSI-L, MSI-H), PD-L1, DNA mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), CIMP markers (p16, MINT1, MINT2, MINT31, hMLH1), promoter methylation of p16, RUNX3, NEUROG1. CIMP was assessed by methylation-specific PCR for five methylation panel markers (p16, MINT1, MINT2, MINT31, hMLH1), and MSI status was validated by PCR using five NCI markers (BAT-26, BAT-25, D5S346, D17S250, and S2S123). KRAS and BRAF mutation was analyzed by direct sequencing using sequence-specific primers from the acquired biopsy specimens. PD-L1, EGFR, MMR expression was examined using immunohistochemistry.
Fecal microbiota analysis in patients with colorectal adenoma and CRC
Time frame: through study completion, an average of 1 year
Using next-generation sequencing technique, fecal microbiota of patients with colorectal adenoma and CRC as well as healthy control was evaluated to verify carcinogenesis-related microbiota.
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 24 Apr 2026.
- Derived from this study: PubMed 42494363Choi Y, Kim N, Song CH, Oh HJ. Sex Hormone Receptor Profiling Reveals an Association between Estrogen Receptor beta-NRF2 Signaling and Improved Outcomes in Colorectal Cancer Patients. Gut Liver. 2026 Jul 24. doi: 10.5009/gnl250538. Online ahead of print.
- Derived from this study: PubMed 36802389Choi J, Kim N, Nam RH, Kim JW, Song CH, Na HY, Kang GH. Influence of location-dependent sex difference on PD-L1, MMR/MSI, and EGFR in colorectal carcinogenesis. PLoS One. 2023 Feb 21;18(2):e0282017. doi: 10.1371/journal.pone.0282017. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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. This study is not recruiting at the moment.
Nayoung Kim, M.D., Ph.D study chair
Seoul National University Bundang Hospital
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 Cancer and Colorectal Adenoma, run by Seoul National University Bundang 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638542, which also lists 2 linked publications.
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 24 Apr 2026.