A Pilot Study on Comparative Evaluation of Results of Pap Smears and HPV Hybrid Capture 2 Performed on Cervical Samples Before and After Application of Acetic Acid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Comparative Evaluation Of Results Of Pap Smears And HPV Hybrid Capture 2 Performed On Cervical Samples Before And After Application Of Acetic Acid.
研究概览
简要总结
This is a pilot study to assess the cell adequacy and quality of Pap smears and adequacy of samples for HPV DNA virus test done after application of 5%acetic acid in a VIA test.Normally a Pap test and HPV DNA test is performed before application of acetic acid. It is assumed that application of acetic acid may alter the cell adequacy of Pap test and HPV DNA test, if any of the above tests is done immediately after VIA test.The present study aims to see the effect of 4-5% acetic acid [vinegar] on the cell adequacy and quality of Pap smear and sample adequacy for HPV DNA test.
详细描述
Aim (of pilot study):
To evaluate the cell adequacy and smear quality of Pap smears and adequacy of samples for HPV HC 2 collected before and after application of acetic acid.
Objective of Pilot study-
- Agreement between the results of HC2 on cervical samples obtained from women before and 5 to 10 mins after VIA test
- Correlation between RLU/ cutoff ratio of HC2 on cervical samples obtained from women before and 5 to 10 mins after VIA test.
- Agreement between the results of cytology on cervical smears obtained immediately before and 5 to 10 mins after VIA test from the same women.
Methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women attending the Preventive Oncology screening clinic.
- •women in age group 30 to 60 years
- •Exclusion Criteria
- •Unmarried women
- •married women in the age group less than 30 years and above 60 years
- •pregnant women
- •women with history of total hysterectomy
- •women with cervical cancer
排除标准
- 未提供
结局指标
主要结局
Comparative Evaluation Of Results Of Pap Smears And HPV Hybrid Capture 2 Performed On Cervical Samples Before And After Application Of Acetic Acid.
时间窗: 3 months
The purpose of this pilot study is to assess the cell adequacy and quality of Pap smears and adequacy of samples for HPV DNA virus test done after application of acetic acid.
次要结局
未报告次要终点
研究者
Gauravi Ashish Mishra
Associate Professor Dept of Preventive Oncology
Tata Memorial Hospital