Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Diagnostic Sensitivity
研究概览
简要总结
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
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
- •Aged at least 18 years
- •Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
- •Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
- •Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
- •Aged at least 35 years
- •Have no previous diagnosis of HNC or HPV-related cancer
- •Fully understands study procedures
- •Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
排除标准
- •Not meeting all of the above inclusion criteria for either the case or control group
研究组 & 干预措施
Case Group
Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.
干预措施: combined HPV 16 DNA and host gene methylation oral biomarker panel (Diagnostic Test)
Control Group
Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use.
干预措施: combined HPV 16 DNA and host gene methylation oral biomarker panel (Diagnostic Test)
结局指标
主要结局
Diagnostic Sensitivity
时间窗: Up to 60 months
A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases.
Diagnostic Specificity
时间窗: Up to 60 months
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.
次要结局
未报告次要终点