NCT02774538已完成不适用
Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV
Institut de Cancérologie de Lorraine6 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2016年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- Agreement between oral and cervical HPV infection
研究概览
简要总结
Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases.
Agreement between cervical and oral HPV infection has been described from a small group of patient. Our study, performed on a greater number of patients, will provide a good estimation of this link, between cervical and oral infection, in a French population of women with a primary cervical 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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic proven of cervical intraepithelial neoplasia or carcinoma in situ (CIS) or invasive cervical cancer or a Pap smear on which at least one HPV has been detected
- •Patients not vaccinated against HPV
- •Age >18 years
- •EOCG performance status ≤ 3
- •Patient must be affiliated to a social security system
- •Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study
排除标准
- •Patients vaccinated against HPV
- •Pregnant woman over 10 weeks
- •Patient who underwent head and neck radiotherapy dating less than one year
- •Patients deprived of liberty or under supervision
结局指标
主要结局
Agreement between oral and cervical HPV infection
时间窗: up to 6 months
Agreement between oral and cervical HPV infection is defined by the presence of at least one identical genotype HPV in both sites in the same wife. All genotypes found in the oral and cervical area will be considered.
次要结局
- Proportion of women with oral HPV infection in women with primary cervical HPV infection(up to 6 months)
- Proportion of women with oral high risk HPV infection(up to 6 months)
- Persistence and clearance of oral HPV infection(up to 18 months)
- Frequency of newly positive women with oral HPV infection(up to 18 months)
- Description of all HPV genotypes found in women with HPV infection at both sites(up to 6 months)
- Oral HPV risk factors(up to 6 months)
- Agreement between full and partial oral and cervical HPV genotypes(up to 6 months)
研究者
研究点 (6)
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