Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 582
- 试验地点
- 2
- 主要终点
- The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC
研究概览
简要总结
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Colorectal cancer group
Patients who are diagnosed with colorectal cancer
Control group
Patients who are not diagnosed with colorectal adenoma or colorectal cancer
Colorectal adenoma group
Patients who are diagnosed with colorectal adenoma
结局指标
主要结局
The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital