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临床试验/NCT01330147
NCT01330147已完成不适用

HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

University of Birmingham8 个研究点 分布在 1 个国家目标入组 937 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
937
试验地点
8
主要终点
Occurrence of HPV in tonsils and in oral scrape sample

研究概览

简要总结

The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.

详细描述

Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
  • Age - 0 to 65 years
  • Subject or legal guardian has given informed written consent

排除标准

  • Subjects undergoing adenoidectomy alone with no tonsillectomy
  • Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated
  • Learning disability preventing an adult over 16 years old from giving their own consent

结局指标

主要结局

Occurrence of HPV in tonsils and in oral scrape sample

时间窗: 36 months

Presence of HPV result

次要结局

  • HPV vaccination status(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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