Association between the microbiome and oral cancer; a comparativestudy from South India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The outcome measure used to compare the microbial profile between the study specimen and control specimen is the relative abundance of various bacteria.
研究概览
简要总结
Title of the Project - Association between microbiome and oral cancer ; a comparative study from South India
There have been many recent studies linking dysbiosis of the oral microbiome with oral carcinogenesis. This creates potential clinical implications with regards to the prognostic, therapeutic and preventive aspects of the management of oral cancer. Just like the Human papilloma virus in oropharyngeal cancer, the oral microbiome profile, or a specific few bacteria may eventually serve as prognostic markers in oral cancer, which can help in improvisation of therapeutic strategies . There have been many studies published related to this topic but to our knowledge there have been no studies profiling this association in the South Indian population with the characteristics of the oral microbiome depending on the local dietary habits and tobacco consumption practices. As a stepping stone towards the objective of profiling microbiomes of local populations in multiple communities, in order to validate its role in oral carcinogenesis, this pilot study evaluates the relative microbial abundance between oral cancer and matched normal tissue in a small cohort of South Indian patients.
Objectives of the study -
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To define oral microbiota associated with oral cancer tissue in South Indian patients and to analyse the oral microbial profile as per smokeless tobacco usage and size/ location of tumour in oral cavity
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This study will help establish oral microbiome profile in normal tissue and oral cancer in a cohort of South Indian Population for the first time. Also, this study will help in understanding the association between oral dysbiosis and carcinogenesis in our set of patients who have a particular risk profile
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Th results of this study are likely to serve as reference data for more extensive and hypothesis driven studies to be conducted in the future.
Description of procedure - For this study , both study specimen and the corresponding matched normal sample (normal mucosa on the contralateral side) will be collected from the same patient on the surgical table, just before full surgical excision is initiated. The specimens would be stored in a preservation solution and transported to the life sciences lab within the same campus. In the life sciences lab, the genomic DNA would be extracted from the tissue specimens using a DNA extraction kit. The extracted DNA would be amplified, sequenced and analysed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment naïve cases of oral cancer hailing from South India, irrespective of the gender of patient and site or stage of oral cancer, who would be managed at the tertiary care hospital attached to our medical school.
排除标准
- •Patients aged less than 18 years, Human Immunodeficiency Virus infection, pre-existing local mucosal diseases or autoimmune diseases, and recipients of chemotherapy or any other medications that would alter the oral microbiome.
结局指标
主要结局
The outcome measure used to compare the microbial profile between the study specimen and control specimen is the relative abundance of various bacteria.
时间窗: The surgical samples will be collected, stored and subsequently analysed for its microbial profile at a single time point (cross-sectional study)
次要结局
- Not Applicable(Not Applicable)