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临床试验/NCT04425122
NCT04425122招募中不适用

The Microbiome of Oesophageal Squamous Cell Carcinoma

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Microbiological culture from biopsy specimens

研究概览

简要总结

This is a prospective study on the microbiota associated with oesophageal squamous cell carcinoma (SCC). Patients with newly diagnosed SCC of oesophagus would be recruited for taking samples of oral and oesophageal rinse, tissue biopsies for investigation of the microbiota of oesophageal cancer. Control patients would be identified from patients scheduled for routine endoscopy.

详细描述

Oesophageal carcinoma significantly contributes to the global cancer burden ranking as the sixth leading cause of global cancer-related death. Oesophageal squamous cell carcinoma (OESCC) is one of the most common type of upper gastrointestinal (UGI) carcinoma in some regions globally, particularly China and Japan in Asia. The disease has an extremely poor prognosis, with overall 5-year survival rates of less than 30%, mainly due to late stage at diagnosis and high likelihood of distant metastases. Although OESCC is associated with risk factors including smoking and alcohol, the aetiology of OESCC is still poorly understood.

Increasing evidence indicates a key role for bacterial microbiota in carcinogenesis. Emerging data implicates the human microbiome in a variety of cancers, most notably Fusobacterium in colorectal cancer and Helicobacter in gastric cancer. The consortium of bacterial microbiome colonizing the gastrointestinal tract is extensive and interact in a complex manner. The microbiome may interact with genetic and environmental factors to metabolize dietary constituents and xenobiotics, among other functions. When the microbial balance is disturbed, the microbiota could alter host cell proliferation and death, manipulate the immune system, and influence host metabolism, giving rise to carcinoma. Several studies have reported an important role of the human microbiota in upper gastrointestinal carcinoma and found associations between the microbiota and some diseases of the UGI tract, such as esophagitis and Barrett esophagus, and with squamous dysplasia and squamous carcinoma of the oesophagus. Another even less well known is the role of the fungal microbiome in OESCC.

Here the investigators will seek to evaluate the role of the bacterial and fungal microbiome in OESCC and the host microbe interactions that may play a role in the understanding and management of OESCC.

Study questions:

  1. Does the microbiome differ between OESCC and normal patients?
  2. Does the microbiome change from normal through premalignancy to malignancy?
  3. What are the mechanisms involved in the microbiome and the development or progression of OESCC?

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

入选标准

  • Patients undergoing an OGD without a history of malignancy
  • 18 Years and older
  • Able to provide informed consent
  • No cognitive impairment

排除标准

  • On anticoagulation including Plavix, warfarin and NOAC's

结局指标

主要结局

Microbiological culture from biopsy specimens

时间窗: 1month

Pattern of culture from specimens obtained, compared between cancer and non-cancer

次要结局

  • Overall survival(5 year)
  • Disease specific survival(5 year)
  • Loco-regional recurrence free survival(5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hon Chi Yip

Associate Consultant

Chinese University of Hong Kong

研究点 (1)

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