A cross sectional investigation into the possible association between Porphyromonas gingivalis strains isolated from the Oral Microbiome and Oro-Oesophageal Cancer patients by MALDI-TOF MS and AP-PCR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Arbitrarily primed polymerase chain reaction (AP-PCR) fingerprinting of P. gingivalis isolates from dental plaque, saliva, healthy and tumour tissue in patients with Oral/ Oesophageal cancers
研究概览
简要总结
| Background: |
Oral cancer is the most common cancer in India amongst men, and accounts for around 30% of all cancers in India. Oesophageal cancer is the 6th most common cancer in India. Along with the common risk factors like tobacco and alcohol, bacteria have been established as risk factors for cancer. Porphyromonas gingivalis (P. gingivalis) is an anaerobic gram-negative bacterium that colonizes the oral epithelium and has been strongly associated with periodontal disease. It has been detected in both Oral squamous cell carcinoma (OSCC) and oesophageal squamous carcinoma tissue.
Reliable data addressing the impact of this bacterium and periodontitis on the causation of Oro-Oesophageal malignancies remain scarce. Mere presence of the same species of an oral pathogen in the tumour tissue and in the periodontal pockets of a patient suffering from periodontal disease does not indicate an association between malignancy and periodontitis. Since P. gingivalis has a strong association with periodontal diseases, examination of whether identical strains of P. gingivalis can be isolated from Oro-Oesophageal cancers and dental plaque specimens obtained from the same patient will go a long way in throwing light on the possible causal association between periodontal disease and Oro-Oesophageal malignancies.
· Aim: Exploring the association between Porphyromans Gingivalis strains isolated from Dental Plaque and from the tumor tissue of Oro-Oesophageal cancer patients
Objectives
· To estimate prevalence rate of P. gingivalis in patients with Oral / Oesophageal cancers using anaerobic culturing and MALDI-TOFMS.
· Perform strain typing of P. gingivalis isolates from the saliva, dental plaque, tumour tissue and adjoining healthy tissue of patients with Oral / Oesophageal cancer using Arbitrarily primed polymerase chain reaction (AP-PCR).
· To explore the association between the P. gingivalis strains isolated from the dental plaque with those isolated from the cancerous tissue.
· To validate saliva as a potential non invasive diagnostic fluid for P. gingivalis isolation.
· To correlate P. gingivalis strains with periodontal health status
Sample size : Oesophageal cancer patients: 80; Oral cancer patients: 85
Duration of study : 3 year
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 74.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from Oral Squamous Cell Carcinoma Patients suffering from Oesophageal Squamous Cell Carcinoma Patients who have not yet undergone any Surgical therapy/ Chemotherapy/ Radiotherapy for treatment of the carcinoma Patients willing to give informed consent Patients with minimum 20 teeth.
排除标准
- •Patients with any malignancy other than squamous cell carcinoma of the oral cavity/ esophagus Patients undergoing any treatment for carcinoma or its recurrence History of antibiotic use in the previous three months Pregnant or lactating females Patients who received periodontal treatment within the last 6 months Patients who require antibiotic prophylaxis before examination Patients unwilling to participate in the study.
结局指标
主要结局
Arbitrarily primed polymerase chain reaction (AP-PCR) fingerprinting of P. gingivalis isolates from dental plaque, saliva, healthy and tumour tissue in patients with Oral/ Oesophageal cancers
时间窗: baseline
次要结局
- To estimate the prevalence of Periodontal disease in patients suffering from Oral/ Oesophageal cancers by recording the Periodontal status of all subjects
- Correlation of the prevalence rate of P.gingivalis in saliva with that in dental plaque samples and tumour tissues(baseline)
- Estimation of prevalence rate of P. gingivalis in saliva & dental plaque of patients with Oral/ Oesophageal cancers using MALDI-TOF MS(baseline)
- Estimation of prevalence rate of P. gingivalis in healthy and tumour tissue of patients with Oral/ Oesophageal cancers using MALDI-TOF MS.(baseline)
- Correlation of P. gingivalis strain with periodontal health status(baseline)