Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp

A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; 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 Type: Observational
• Enrollment (Actual): 582

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited Seoul National University Bundang Hospital for gastrointestinal symptomes or regular check-ups, and agreed to participate.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Nayoung Kim, M.D., Ph.D, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Choi 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 30, 2021
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Carcinogenesis; Sex difference; Tumor location
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Carcinogenesis
• Other Study ID Numbers: B-1305-203-009

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
• product manufactured in and exported from the U.S.: No