Comparison of PCR based E6/E7 Oncogene detection in cervical cytology and cervical tissue specimen with histopathology in HPV-positive women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Compare the PCR based E6/E7 oncogene testing in cervical cytology to the histopathological diagnosis in HPV positive samples.
研究概览
简要总结
**Study hypothesis:**HPV DNA presence cannot differentiate infectious state from pre-invasive/invasive cervical lesions, hence leading to more unnecessary interventions. Since integration of HPV DNA into the host cell genome is the key step in development and progression of cervical cancer, the detection of E6/E7 oncogenes can be used as a promising tool for triaging HPV positive women in detecting preinvasive lesions.
In this study we will evaluate whether PCR based E6/E7 oncogene detection in cervical cytology and tissue samples help in diagnosing preinvasive lesions of cervix in HPV positive women, and will also evaluate the performance of E6 &7 oncogene detection as an optional triage for HPV positive women using cervical cytology and cervical tissue samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged ≥ 30 – 65 years
- •No previous history of cervical lesions or cervical cancer
- •Willing to participate in the study after informed written consent.
排除标准
- •Pregnancy
- •Inadequate cervical cytology/tissue sample
- •Active PID, genital infection, vaginal discharge
- •Previously treated for preinvasive or invasive lesions of cervix.
结局指标
主要结局
1. Compare the PCR based E6/E7 oncogene testing in cervical cytology to the histopathological diagnosis in HPV positive samples.
时间窗: 1. After getting test results | 2. At the end of the study, by June 2026
2. Compare the PCR based E6/E7 oncogene testing in cervical tissue to the histopathological diagnosis in HPV positive samples.
时间窗: 1. After getting test results | 2. At the end of the study, by June 2026
次要结局
- 1. Compare E6 & E7 oncogene detection in cervical cytology & tissue samples with final histopathology results(2. Compare the E6/E7 oncogene detection rates in cervical cytology with HPV positivity)
研究者
Dr Shaloo Priya
AIIMS, New Delhi