Understanding the Interplay of Oral Microbiome in Progression of Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The primary outcome of this study is the analysis of microbiome composition, including bacterial diversity, dysbiosis patterns, and microbial taxa distribution. This will be assessed by comparing microbiome profiles among healthy individuals, individuals with premalignant conditions, and patients diagnosed with oral squamous cell carcinoma (OSCC).
研究概览
简要总结
Background and Rationale: OSCC is one of the significant public health challenges, particularly in countries like India, where the prevalence of the disease is high, supposedly due to lifestyle and environmental risk factors. Even though there are advancements in diagnostics and treatment in current times, the survival rates for patients with OSCC are relatively low, mainly because of diagnosis at the advanced stages and a lack of deeper understanding into early disease mechanisms. Recent studies have paved the way for interlinking oral cancer with the microbiome of the oral cavity, yet the specific interplay between the oral microbiome and OSCC progression remains poorly understood. This study aims to bridge this critical research gap on longitudinal analyses of microbiome shifts from premalignant conditions to OSCC. The findings could enhance our understanding of pathogenesis in OSCC, aiding the development of microbial biomarkers for early detection and prognostics of OSCC. In the future, these findings could also implicate the development of novel microbiome-targeted therapeutic interventions to control and combat OSCC.
AIM
To investigate the role of the oral microbiome in the progression and development of oral squamous cell carcinoma (OSCC) by studying the microbiome shifts over time in patients at different stages of OSCC progression.
Objectives:
1. To characterize the composition and diversity of the oral microbiome in OSCC patients compared to healthy controls.
2. To investigate changes in the oral microbiome during disease progression from premalignant lesions to early malignant OSCC.
3. To correlate specific microbial genera and dysbiosis associated with clinical and pathological features of OSCC.
4. To identify potential microbial biomarkers for early diagnosis and prognosis of OSCC based on microbial signatures.
Hypothesis: The composition and dynamics of the oral microbiome are associated with the development and progression of OSCC through the modulation of inflammatory mechanisms and the tumor microenvironment.
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
- •The person (irrespective of sex) should have been diagnosed with Oral Squamous Cell Carcinoma.
- •Pre-malignant stages (ulcers, early lesions) and early malignant stages (T1 and T2) cases will be considered for the study.
- •Patients with and without tobacco chewing, areca nut chewing, smoking, and alcohol consumption will be considered for the study.
排除标准
- •Individuals who are less than 18 years of age.
- •Patients diagnosed with late stages of OSCC (T3 and T4).
- •Patients characterized with highly malignant and metastatic OSCC with signs of excessive tumour outgrowth leading to the opening of mouth and trismus.
结局指标
主要结局
The primary outcome of this study is the analysis of microbiome composition, including bacterial diversity, dysbiosis patterns, and microbial taxa distribution. This will be assessed by comparing microbiome profiles among healthy individuals, individuals with premalignant conditions, and patients diagnosed with oral squamous cell carcinoma (OSCC).
时间窗: All outcomes will be assessed at a single time point, specifically at baseline, upon sample collection from cases and controls. Since this is a case-control study, no follow-up assessments will be conducted, and microbiome analysis will be based on retrospective comparison between study groups.
次要结局
- Secondary outcomes include comprehending the Dysbiosis Index to quantify microbial imbalance across the study groups and the identification of specific microbial taxa that may be associated with the progression from a non-cancerous state to OSCC.(Single time point at baseline (upon sample collection))
研究者
Dr Bharath Prasad A S
Manipal School of Life Sciences