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临床试验/CTRI/2024/03/064727
CTRI/2024/03/064727尚未招募不适用

Oral Microbiome and Inflammatory markers in Oral Cancer, Pre-Malignancy and Normal Individuals – A Comparative Study.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
• Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments

研究概览

简要总结

**i.**Title: Oral Microbiome and Oncogenic cytokines in development of Oral Cancer Rationale: Approximately 13% of global cancer burden are directly attributed to infectious agents due to Chronic inflammation and Microbial pathogens.  Human Oral Microbiome Database reports existence of 774 bacterial species.Presence of pro-inflammatory microbes promotes carcinogenetic modulation of cell metabolism resulting in different cytokines that enhance tumor cell proliferation and survival.Pro-inflammatory cytokines are associated with increased oral mucosal damage with higher concentrations of IL-6, IL-8 & TNF-α (oncogenic cytokines) reported in saliva of Oral cancer patients.  Hence, altered microbiomes and salivary oncogenic cytokines, associated with oral inflammation, make potential biomarkers for disease diagnosis.    Novelty: Microbiome profile & oncogenic cytokines, and its association in development of oral cancers are not well established.  We plan to undertake exploratory study to understand their potential role and its association with risk for oral cancer development.   Objectives:Identifying (1) Microbiome and (2) Oncogenic cytokines in Salivary and Buccal mucosal scraping samples in Oral Cancers, Pre – Malignancy & Healthy Individuals.To identify relative distribution of microbes and oncogenic cytokines. Methods·  Whole genome shotgun metagenomic sequencing (platform: Next generation sequencing) will be used to measure overall oral microbiomes followed by Bioinformatics analysis.·         Chemiluminescence & ELISA for Oncogenic cytokines   Expected outcome:  Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments   To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adults (18 to 70 ) who have been diagnosed with oral dysplasia Adults (18 to 70 ) or who have been diagnosed with oral malignancies.
  • Healthy controls (18 to 70 ) free of any oral lesions.

排除标准

  • •Adults refusing to participate in the study.
  • •Exclusion criteria for Healthy Participants: Individuals with active dental infection/recent antibiotic use/anti-septic mouthwash use will be excluded from the study.

结局指标

主要结局

• Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments

时间窗: • Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments | • To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.

• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.

时间窗: • Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments | • To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.

次要结局

  • Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments(• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Mr Rajendra babu Ankam

Homibhabha Cancer Hospital Research center

研究点 (1)

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