Improving Detection and Early Action for HPV-positive Oropharynx Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Prevalence of circulating HPV DNA
研究概览
简要总结
This study aims to determine whether a blood test for HPV DNA can improve diagnosis of HPV-positive oropharynx cancer (HPV-OPC).
详细描述
The diagnosis of HPV-OPC is often delayed. In this study, individuals with signs or symptoms potentially related to HPV-OPC, such as unexplained throat pain, tonsil or tongue base asymmetry, or a neck mass, will have their blood tested for circulating HPV DNA. A positive test may indicate that their symptoms are caused by HPV-OPC, and their treating physician will be encouraged to complete all the necessary testing to determine whether this is the case.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neck mass present for >2 weeks with no signs/symptoms of infection
- •Neck mass present for >2 weeks with signs/symptoms of infection that did not resolve with antibiotic therapy
- •Palatine or lingual tonsillar asymmetry on physical exam
- •Palatine or lingual tonsillar asymmetry on imaging, including asymmetric FDG uptake in palatine or lingual tonsils on PET-CT scans
- •Unexplained throat pain for >2 weeks that did not resolve with antibiotic therapy
排除标准
- •Known diagnosis of HPV-OPC
结局指标
主要结局
Prevalence of circulating HPV DNA
时间窗: Test results are returned within 1 week.
Proportion of participants with circulating HPV DNA detected in their blood.
次要结局
- Impact on clinical practice(Within 2-3 weeks of study enrollment)
- HPV-OPC awareness(At the time of study enrollment)
- Predictive value of circulating HPV DNA(Long-term follow-up for up to 2 years)
研究者
Eleni M. Rettig, MD
Principal Investigator
Brigham and Women's Hospital