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临床试验/NCT02809352
NCT02809352已完成不适用

Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)

CHU de Reims1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
348
试验地点
1
主要终点
HPV genotyping

研究概览

简要总结

Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.

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
31 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • to live in the Ardennes department (France)
  • affiliation to a health insurance organism
  • 31 to 65 years old

排除标准

  • current follow-up for cervical cytological abnormalities
  • history of hysterectomy
  • reimbursement for a Pap smear in the last 3 years

结局指标

主要结局

HPV genotyping

时间窗: Day 0

DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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