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临床试验/NCT03173001
NCT03173001进行中(未招募)不适用

Intestinal Helminths and Protozoan Infections in Patients With Colorectal Cancer: Prevalence and Possible Association With Cancer Pathogenesis

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan0 个研究点目标入组 500 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
主要终点
Prevalence of intestinal protozoa (commensals) in patients with colorectal cancer and association with cancerogenesis

研究概览

简要总结

Colorectal cancer (CRC) has the third highest cancer incidence in the world. There is mounting evidence that the intestinal microbiota plays an important role in colorectal carcinogenesis. but there is no information on protozoa of intestinal microbiota except Blastocystis hominis, although data on this issue is scarce. In this study we are going to evaluate the prevalence of intestinal helminthes and protozoa in CRC patients and control group that includes random residents. Patients will be examined before, after surgery and chemotherapy. Parasites and protozoan infection intensity will be estimated by triple coproscopy.

详细描述

The study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Diseases and Research Center of Oncology, Ministry of Public Health of the Republic of Uzbekistan.

All the CRC patients from Research Center of Oncology will be examined with their written concent. Diagnosis of CRC is based on the results of clinical examination, endoscopic, histological, X-ray and laboratory data according to International Classification proposed by the American Joint Committee on Cancer (AJCC) with application TNM (T-tumor, N-nodus, M-metastases) for diagnosis. Descriptors in T (primary tumor) mean the degree of the tumor spreading in layers of the intestine; descriptors in N mean absence of metastases or the number of lymph nodes with metastases; descriptors in M shows absence or presence of remote metastases.

The control group will be a random residents of Tashkent city without any complaints from gastrointestinal tract matched by gender and age to the patients with CRC. Age of individuals under examination will be taken at the range from 17 to 90 years old.

Collection of stool samples Three stool samples for parasitological examination will be taken from both control subjects and CRC patients at 1-2 days interval. Stool samples were collected in individual containers, containing 5 ml of Turdiev's preservative provided conservation and staining of protozoa cysts and eggs of worms for a year. The Turdiev's preservative includes:80 ml of 0.2% aqueous solution of sodium nitrite, 10 ml of formaldehyde, 2 ml of glycerin, 8 ml of Lugol's solution, 250 ml of distilled water.

Collection of material for C. parvum (Cryptosporidium parvum) detection in stool samples will be carried out by preparation of fresh feces thin smears.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with colorectal cancer before, after surgery and chemotherapy.
  • For control group:
  • Includes all individuals that doesn't have any complaints from gastrointestinal tract

排除标准

  • Age before
  • Patients with other gastrointestinal disorders
  • Patients with any chronic concomitant diseases

结局指标

主要结局

Prevalence of intestinal protozoa (commensals) in patients with colorectal cancer and association with cancerogenesis

时间窗: from 2015 to 2018 years

In this study we are going to determine their prevalence and role in the development of colorectal cancer

Prevalence of Lamblia intestinalis and Cryptosporidium parvum in patients with colorectal cancer and association with cancerogenesis

时间窗: from 2015 to 2018 years

In this study we expect to find pathogenic protozoa in patients with colorectal cancer and determine their role in the development of colorectal cancer

Prevalence of intestinal helminths in patients with colorectal cancer and association with cancerogenesis

时间窗: from 2015 to 2018 years

In this study we expect to find intestinal helminths in patients with colorectal cancer and determine their role in the development of colorectal cancer

次要结局

未报告次要终点

研究者

发起方
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Svetlana Osipova, MD, PhD, DS

Professor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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