Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 799
- 试验地点
- 2
- 主要终点
- Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components.
研究概览
简要总结
The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- •Male or female, aged 18 years or above
- •Referred to lower GI endoscopy. Referral reasons can be among others:
- •Positive FOBT (Fecal Occult Blood Test)
- •Follow up after polypectomy
- •Screening because of age
- •Abdominal pain
- •Familial or past history of colon cancer or adenoma
- •Abnormal imaging such as barium enema
- •Change in bowel habits
- •Both self-referrals, referrals from external GP or specialists and internal referrals can be included.
排除标准
- •Previous diagnosis of an inflammatory bowel disease
- •Previous diagnosis of intestinal polyposis syndrome
- •CRC patients
- •Inclusion criteria:
- •Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- •Male or female, aged 18 years or above
- •Diagnosis of CRC for which resection is planned
- •Both internal and external referrals from specialists can be included
- •Exclusion Criteria:
- •Previous diagnosis of an inflammatory bowel disease
- •Previous diagnosis of intestinal polyposis syndrome
结局指标
主要结局
Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components.
时间窗: 2 years
Host microbiome composition and abundance data will be generated from saliva, stool and colonic biopsies with amplicon-based 16S ribosomal RNA sequencing. This data will be correlated to CRC risk factors collected in a questionnaire covering lifestyle, diet and medical history as well as host genomic and transcriptomic profiling generated by targeted gene sequencing and microarray-based gene expression profiling.
次要结局
未报告次要终点