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临床试验/NCT03709485
NCT03709485
Unknown
不适用

Analysis of Gut Microbiome in Prostate Cancer Patients

Ziv Hospital0 个研究点目标入组 150 人2018年11月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Prostate Cancer
发起方
Ziv Hospital
入组人数
150
主要终点
Characterization of gut microbiome
最后更新
7年前

概览

简要总结

The research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. In consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. The gut flora will be examined and characterized by a microbiome analysis tool. Negative patients will serve as internal control. The investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.

详细描述

Prostate cancer is the no. 1 cancer among men. Risk factors include Afro-American origin, prostate cancer in a first degree relatives and the presence of BRCA2 genetic mutations. No specific association has been described yet between prostate cancer and specific gut bacteria. The GI tract is the home of billions of bacteria. The microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. The microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of GI content. All of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs. The purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.

注册库
clinicaltrials.gov
开始日期
2018年11月1日
结束日期
2019年12月30日
最后更新
7年前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

发起方
Ziv Hospital
责任方
Sponsor

入排标准

入选标准

  • male gender
  • age above 45
  • referred for prostate biopsy

排除标准

  • age below 45
  • antimicrobial therapy in the 7 days prior to biopsy
  • previous prostate or pelvic irradiation
  • patients who suffer from inflammatory bowel disease
  • systemic chemotherapy for any reason in the 3 months prior to the biopsy.

结局指标

主要结局

Characterization of gut microbiome

时间窗: 1 year

Analysis of rectal swab cultures.

Association of prostate cancer patients and specific microbes.

时间窗: 1 year

Relationship between patients with prostate cancer and specific strains of rectal microbes

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