NCT02981862已完成不适用
Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.
Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月19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
- 100
- 试验地点
- 2
- 主要终点
- Assessement of CaptHPV method
研究概览
简要总结
The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Patient with cervical cancer, vulvar cancer, anal cancer, oropharynx cancer, oral cavity cancer or penis cancer
- •Patient naive of any treatment for this pathology
- •Patient capable and willing to follow all procedures of the study in accordance with the study
- •Ability to provide an informed written consent form
- •Affiliation to a social security system
排除标准
- •Patients who have already undergone surgical treatment leading to complete removal of the lesions or who have started treatment with radiotherapy and / or chemotherapy
- •Patient whose health status contraindicates a blood sample of 20 ml,
- •Absence of informed written consent form
- •Pregnant or breast feeding females
- •Patients deprived of liberty or under supervision
结局指标
主要结局
Assessement of CaptHPV method
时间窗: 1 day
The diagnostic value of the serum marker provided by the method CaptHPV will be assessed in sensitivity and specificity to results of histological and virological analyzes of a sample tumor.
次要结局
未报告次要终点
研究者
研究点 (2)
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