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临床试验/NCT02845973
NCT02845973已完成不适用

Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,325 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,325
试验地点
1
主要终点
differences in abundance of gut microbiota

研究概览

简要总结

The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.

详细描述

Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age from 40 to 85 years old
  • Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
  • Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery

排除标准

  • Patients with history of colorectal cancer
  • Patients with long term use of antibiotics or probiotics
  • Patients with uncontrolled diabetes, hypertension or hepatitis
  • Patients with a history of subtotal gastrectomy or partial bowel resection
  • Patients who are not able to cooperate
  • Patients with medical conditions who are not appropriate to participate the study
  • Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.

结局指标

主要结局

differences in abundance of gut microbiota

时间窗: 1 year

differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)

次要结局

  • evidence of colorectal neoplasia(1 year)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing-yuan Fang, MD, Ph. D

Chief, Division of Gastroenterology and Hepatology

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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