Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Prevalence of salivary TTMV-HPV DNA
研究概览
简要总结
The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').
详细描述
This cross-sectional study will characterize the prevalence of salivary TTMV-HPV DNA among participants with and without HPV-positive throat cancer
Oral HPV infection is common among healthy adult men, but most of these infections resolve spontaneously and only a very small percentage of oral HPV infections turn into HPV-positive throat cancer. This study is trying to understand whether this new oral rinse test detects HPV DNA from infection, cancer cells, or both. If this test is ONLY positive in people WITH cancer, it may be useful for diagnosing HPV-positive throat cancer in the future.
Along with the oral rinse test study participants will complete brief surveys and participants with a positive salivary TTMV-HPV DNA tests may have repeat saliva testing, blood tests and head/neck exam.
It is expected that about 360 people will take part in this research study.
An external laboratory called Naveris is supporting this research study by providing testing for HPV DNA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18+ years
- •Able to provide informed consent
- •Either one of the following:
- •Control cohort: Male individuals WITHOUT head and neck tumors that are, or may be, HPV-positive
- •Case cohort: Any individual WITH incident, untreated HPV-positive oropharynx squamous cell carcinoma
排除标准
- •Unable to provide informed consent
- •Head and neck tumors of non-oropharynx subsites that are or may be HPV-positive, including oral cavity, sinonasal, laryngeal, hypopharyngeal, or nasopharyngeal squamous cell carcinomas
结局指标
主要结局
Prevalence of salivary TTMV-HPV DNA
时间窗: 12 months
Percentage of controls without cancer compared with percentage of cancer patients who have TTMV-HPV DNA detected in their saliva
次要结局
未报告次要终点
研究者
Eleni Marie Rettig, MD
Principal Investigator
Dana-Farber Cancer Institute