Validation Of A Panel Of Methylated Genes for Screening Of CervicalCancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Primary outcome: To see whether data obtained in tissue samples
研究概览
简要总结
Cervical cancer is still a major cause of mortality in women in developing
countries. PAP smear which has been successfully implemented to reduce incidence of cancer in
developed world has not been effective in the same way in developing world important reason
being no national policy for screening coupled with low sensitivity of a single pap smear. Thus,
there is a need to develop an objective screening tool which is very sensitive, specific and
reproducible. This study is an extension of our earlier work where we proved epigenetic alterations
in a panel of 11 genes was very helpful to detect cervical lesions. In this study, we are trying to
exploit same results in cytological samples to use it as invasive tool.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •All patients diagnosed with LSIL, HSIL and Cancer cervix based on PAP smear or biopsy will be included as cases.
- •Women who are attending Kasturba Hospital, Manipal gynaecology OPD with benign pathologies of genital tract with normal cervix on speculum will be included as controls.
排除标准
- •Not willing to participate in study.
- •Patient on immunosuppressive therapy.
- •Previously treated for any other cancers.
结局指标
主要结局
Primary outcome: To see whether data obtained in tissue samples
时间窗: at the end of 2 years
can be translated in cytology samples, to be used as effective screening tool.
时间窗: at the end of 2 years
次要结局
- Secondary outcome measure: Comparison of methylation status of(various panel of genes in normal, pre-malignant and malignant lesions of cancer cervix.)