Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
概览
- 阶段
- 不适用
- 干预措施
- combined HPV 16 DNA and host gene methylation oral biomarker panel
- 疾病 / 适应症
- Oropharyngeal Cancer
- 发起方
- H. Lee Moffitt Cancer Center and Research Institute
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Diagnostic Sensitivity
- 状态
- 招募中
- 最后更新
- 2个月前
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).
研究者
入排标准
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
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
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.