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临床试验/NCT02811367
NCT02811367已完成不适用

The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2016年6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
117
试验地点
1
主要终点
Cervical intra-epithelial neoplasia grade 2 or worse

研究概览

简要总结

The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

详细描述

The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+).

A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening.

The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

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

入选标准

  • women previously positive at HPV testing

排除标准

  • pregnancy

结局指标

主要结局

Cervical intra-epithelial neoplasia grade 2 or worse

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Patrick Petignat

Prof.

University Hospital, Geneva

研究点 (1)

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