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临床试验/NCT01213459
NCT01213459已完成不适用

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2010年4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
420
试验地点
1
主要终点
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.

研究概览

简要总结

This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
  • Women >=15 years of age attending a clinic for routine cervical screening,
  • Written informed consent obtained from the subject and/or subject's parent/guardian.

排除标准

  • Referral for abnormal cervical sample at the current visit,
  • Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
  • No cervical sample provided,
  • History of hysterectomy,
  • Known diagnosis of immunosuppression, or patient on immunosuppressives,
  • Pregnant female >=25 years of age.

结局指标

主要结局

Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.

时间窗: At least 12 months from the date of subject enrolment

次要结局

  • Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.(At least 12 months from the date of subject enrolment)
  • Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.(At least 12 months from the date of subject enrolment)
  • Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).(At least 12 months from the date of subject enrolment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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