Epigenetic Regulation of Colorectal Polyps and Cancer and Its Traceability in Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- microRNA/mRNA expression in polyps and cancer
研究概览
简要总结
The goal of this study is to learn about the epigenetic and genetic regulation (microRNA/mRNA) of colorectal polyps and their evolvement as polyps and to colorectal cancer. Furthermore, the study aims at investigating whether certain epigenetic features, linked to polyps and/or cancer are traceable in blood samples.
The main questions the study aims to answer are:
- Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages?
- Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient?
- Is the intestinal microbiata correlated with colorectal polyps and cancer and their microRNA/mRNA expression?
Type of study: clinical trial Participant population Participants consist of patients undergoing a scheduled colonoscopy where a polyp or cancer is discovered. Healthy controls, with normal colonoscopy findings will be enrolled.
Biopsies will be obtained from polyps/cancers and from normal surrounding intestinal mucosa. Biopsies will be obtained from defined intestinal locations from healthy controls. Blood samples will be collected from all participants.
Researchers will compare microRNA/mRNA and microbiota in patients with polyps/cancers and their respective stages as well as healthy controls. Comparisons include biopsies and blood samples.
详细描述
Scientific Question The study aims to investigate the epigenetic regulation of polyps in the colon and rectum in patients undergoing colonoscopy. The intention is to examine the expression of microRNA/mRNA in blood and intestinal tissue in patients with colorectal polyps or colorectal cancer, as well as in healthy controls. The goal is to learn more about microRNA/mRNA alterations responsible for the evolvement of colorectal polyps and cancer as well as to trace specific microRNA/mRNA expression from polyps and cancer in the blood. Furthermore, the study will analyze the microbiome of the intestines to explore potential associations between the gut microbiota and polyps/cancer, as well as their respective microRNA/mRNA profiles.
Primary Research Questions
Are there specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development?
Does microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood?
Secondary Research Question Does the intestinal microbiota correlate with the presence of polyps and cancer, and their microRNA/mRNA expression?
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
- •Patients over 18 years referred for colonoscopy for examination or evaluation/removal of colorectal polyps.
排除标准
- •Patients with a history of colorectal cancer.
- •Patients not in capacity to understand the study information and give informed consent.
结局指标
主要结局
microRNA/mRNA expression in polyps and cancer
时间窗: 6 months
Investigate specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development
Traceability of microRNA/mRNA expression of polyps and cancer in blood
时间窗: 6 months
Investigate whether microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood
次要结局
- Correlation of Intestinal microbiota and microRNA/mRNA expression(6 months)