Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CIN III (cervical intraepithelial neoplasia) lesions
研究概览
简要总结
The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.
The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction].
The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Positive informed consent
- •Patients with suspected preinvasive genital lesion
- •Patients with confirmed genital lesion (both preinvasive and invasive)
- •Contact via dept. of obs/gyn of luebeck university
- •Complete set of data
排除标准
- •Incomplete set of data
- •Negative informed consent
结局指标
主要结局
CIN III (cervical intraepithelial neoplasia) lesions
时间窗: three years
number of CIN III lesions
cervical cancer
时间窗: three years
number of cervical cancer probes
HPV
时间窗: three years
number and type of HPV infection of the analyzed probes
次要结局
未报告次要终点
研究者
Daniel Alexander Beyer
Priv.-Doz.Dr.med.habil.
University of Luebeck