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

NCT05638542 | Active Not Recruiting

• 1 other identifier: B-1305-203-009
• Study Type: observational
• Target: 582
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer; Colorectal Adenoma

Keywords

Carcinogenesis; Sex difference; Tumor location

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36802389 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Endoscopically biopsied samples, blood samples, fecal samples

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinogenesis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nayoung Kim, M.D., Ph.D

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 6, 2022
• Study Start: March 1, 2015
• Primary Completion: January 30, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)