跳至主要内容
临床试验/CTRI/2025/02/080509
CTRI/2025/02/080509尚未招募不适用

Fecal Microbiome Analysis in Indian Colorectal Cancer Patients- An Exploratory Study

Aster CMI Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1) To analyse the prevalent gut microbiome in the Indian CRC patients and compare it to the data from the non CRC or healthy cohort

研究概览

简要总结

The incidence of colorectal cancer (CRC)in on the rise in countries which traditionally were thought to have lower rates, this includes India where the incidence is alarmingly getting higher with every decade. The focus on the association between gut microbiome and the development of CRC is evolving rapidly. The gut microbiome has an important role in the carcinogenesis by causing the initial inflammation and modulating different signalling pathways. In a dysbiotic state the response and resistance to systemic anti-cancer therapies is also governed by the gut microbiome. This establishes a prognostic and predictive value to the detection of pathogenic biomarkers in the stool and could also serve as good screening tool for early detection of CRC. The major hindrance to comprehensive understanding of the role of the microbiome in CRC biology is the lack of diversity of sample populations. Majority of the available data is from western stool samples. The limited Indian data available clearly shows a difference in the prevalence of carcinogenic bacteria hence making the western data irrelevant

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age above 18 at the time of informed consent.
  • 2.Willing to give Informed consent 3.Confirmed diagnosis of CRC for which no treatment was initiated.

排除标准

  • 1.unwilling to consent 2.usage of antibiotics, antivirals, anti parasitic agents in the last 3 months 3) usage of immunosuppressive medications – 3 months 4) Major surgery to the gastrointestinal tract in the previous 5 years 5) usage of probiotics greater than 1000000000 cfu per day in the last 6 months.

结局指标

主要结局

1) To analyse the prevalent gut microbiome in the Indian CRC patients and compare it to the data from the non CRC or healthy cohort

时间窗: DNA sequencing of the gut microbiome at 2 time points. Baseline and 6 Months post treatment

2) To observe the change in the microbiome post definitive anti-cancer treatment

时间窗: DNA sequencing of the gut microbiome at 2 time points. Baseline and 6 Months post treatment

次要结局

  • To observe the change in the microbiome post definitive anticancer treatment(Two time points)

研究者

发起方
Aster CMI Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Velukuru Sai Vivek

Aster CMI Hospital

研究点 (1)

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