Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- presence of high-risk papillomavirus in the analysis of cervical smear
研究概览
简要总结
High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged from 25 to 65 years
- •consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
- •signature of the informed consent
- •affiliated to Social Security
排除标准
- •women vaccinated against HPV
- •women who received a treatment for a cervical pathology followed by a normal
- •women with a known positive HIV test
- •women suffering from a chronic pathology that generate immunosuppression
- •Women currently treated with immunosuppressors
- •Women treated with corticoids currently or dating of less than 6 months
- •protected by law
结局指标
主要结局
presence of high-risk papillomavirus in the analysis of cervical smear
时间窗: during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
时间窗: during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
时间窗: during 36 months after inclusion
次要结局
未报告次要终点