跳至主要内容
临床试验/NCT03604588
NCT03604588Unknown不适用

Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers

Gustave Roussy, Cancer Campus, Grand Paris2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月17日最近更新:
适应症
干预措施

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

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

Other

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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