Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
研究概览
简要总结
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated oropharynx epidermoid carcinoma
- •Patient ≥ 18 years old
- •Patient affiliated to a social security scheme or beneficiary of such a scheme
- •Information to the patient or his legal representative and signature of informed consent
排除标准
- •Non-oropharyngeal epidermoid carcinoma
- •Oropharyngeal epidermoid carcinoma previously treated
研究组 & 干预措施
Patients with oropharyngeal cancer
Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.
Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.
干预措施: HPV OncoTect™ (Diagnostic Test)
结局指标
主要结局
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
时间窗: up to 12 months
次要结局
未报告次要终点