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

Active, not recruiting

• Conditions: Colorectal Cancer; Colorectal Adenoma

• Registration Number: NCT05638542
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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 Timeline

• Study Start: 2015-03-01
• Primary Completion: 2021-01-30
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-27
• Study First Posted: 2022-12-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 582

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fecal microbiota analysis in patients with colorectal adenoma and CRC	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.
The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of