Prevalence of Oral Human Papillomavirus (HPV) associated oropharyngeal squamous cell carcinoma (OSCC) among patients attending a tertiary care center in Mangalore - A prospective study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. To assess the oral HPV prevalence among OSCC patients. This is crucial for devising appropriate strategies and for identifying highrisk groups that require targeted interventions.
研究概览
简要总结
This is a prospective study that aims to determine the prevalence of different HPV genotypes in HPV associated oropharyngeal squamous cell carcinoma (OSCC). The study will be using 120 tissue biopsy and saliva samples collected from histologically confirmed OSCC positive patients from the year 2024 to 2025. The biopsy samples collected would be processed and tested by chip-based Trunat® HPV-HR kit PCR and the Truenat positive samples (HPV HR types 16/31 and 18/45) will be genotyped by conventional multiplex PCR. E6 and E7 oncogenes of HPV HR types 16 and 18 will be sequenced by Sanger sequencing and bioinformatic analysis will be performed. The Trunat® negative samples would be subjected to multiplex PCR for detecting other HR HPV. The study will help in estimating the current prevalence and burden of oral HPV in the Indian population and the impact of socioeconomic and behavioral risk factors associated with OSCC. Furthermore, study also aims to explore the use of non-invasive samples like saliva as an alternative oral HPV testing strategy among OSCC patients.
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
- •Patients above the age of 18 years with class III/IV oral cancer II.
- •Patients complying to provide consent for the study.
排除标准
- •Oral cancer patients not undergoing surgery for removal of tumors II.
- •Patients not willing to give consent for the study.
结局指标
主要结局
1. To assess the oral HPV prevalence among OSCC patients. This is crucial for devising appropriate strategies and for identifying highrisk groups that require targeted interventions.
时间窗: 6 Months
2. Study will help in the identification of other high-risk HPV among OSCC patients.
时间窗: 6 Months
3. The study will also explore saliva testing as a strategy for testing oral HPV among cancer population
时间窗: 6 Months
4. The study is also aimed to identify the impact of different risk factors associated with OSCC.
时间窗: 6 Months
5. Study will provide insights regarding mutational status of E6 and E7 oncogenes.
时间窗: 6 Months
次要结局
- 4. The study is also aimed to identify the impact of different risk factors associated with OSCC.(5. Study will provide insights regarding mutational status of E6 and E7 oncogenes.)
研究者
Dr Anitha J
Manipal Academy of Higher Education