Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
研究概览
简要总结
Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.
详细描述
A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
- •The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.
排除标准
- •The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
- •The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
- •The patients having had a hysterectomy.
- •The patients incapable to receive the information enlightened on the progress and the objectives of the study
- •The patients not having signed enlightened assent
研究组 & 干预措施
1
A cervico-vaginal cervical smear will be realized before every colposcopique examination.
A new cervical taking for the search(research) and the detection of the HPV 16 and 18 will be realized.
干预措施: A cervico-vaginal cervical smear (Procedure)
结局指标
主要结局
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
时间窗: 48 months
次要结局
- The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)(48 months)