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

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

Detailed Description
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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.

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

Conditions
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Colorectal Cancer, Colorectal Adenoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Patients who are not diagnosed with colorectal adenoma or colorectal cancer | |
| Colorectal adenoma group<br>Patients who are diagnosed with colorectal adenoma | |
| Colorectal cancer group<br>Patients who are diagnosed with colorectal cancer | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sex difference, Carcinogenesis, Tumor location