Association of Oral Microbiome Profile with Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Identifying specific bacterial species showing significant variations across study groups and quantifying selected bacterial species.
研究概览
简要总结
This observational study aims to investigate the association between the oral microbiome and the presence of Oral Squamous Cell Carcinoma. As part of the initial work, sequencing will be carried out to analyze 12 samples (4 in each group of oral cancer, individuals with oral potentially malignant disorder, i.e., oral submucous fibrosis, and healthy individuals with tobacco exposure). Subsequently, the microbial profile of patients with oral cancer and healthy individuals will be compared in a total sample size of 216 patients. The primary outcome will be identifying bacterial species showing significant variations across study groups and quantifying selected bacterial species. The secondary outcome will be to develop a predictive model.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with early oral cancer, individuals with oral potentially malignant disorder (OPMD) and healthy individuals with tobacco exposure will be included.
- •Early oral cancer would comprise TNM stages 1 and
- •Oral submucous fibrosis will be considered for OPMD 3)Healthy individuals with tobacco exposure will form the control group.
排除标准
- •Patients on long term steroid therapy, NSAIDs or on antibiotic medication in the previous six weeks will be excluded from the study.
- •Further, those with a prior history of allergies, irradiation, chemotherapy / oncology related surgery and a history of diabetes mellitus or immune-related diseases will be excluded.
- •Pregnant and lactating women will also not be considered for the study.
- •Patients who show flu – like symptoms will be excluded.
结局指标
主要结局
Identifying specific bacterial species showing significant variations across study groups and quantifying selected bacterial species.
时间窗: 36 months
次要结局
- Develop a predictive model(12 months)
研究者
Dr Pratibha G
Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal