Concordance between urine and self-collected vaginal samples for high risk hpv detection in cervical cancer screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,453
- 试验地点
- 1
- 主要终点
- To analyse concordance between first void urine and self collected vaginal sample
研究概览
简要总结
1. Screening activities will involve women in the age group 30 – 60 years through community based screening camps.
2. The procedure will involve self-collection of vaginal samples and first void urine sample.
3. The samples will be tested using Cobas 4800 at hospital laboratory.
4. A questionnaire will be filled up regarding socio-demographic information and acceptability of screening methods.
5. There will be further screening of positive patients by colposcopy followed by treatment which will be either thermal ablation or large loop excision of the transformation zone.
6. Data will be collected on the costs associated with implementation of HPV screening by self sampling and urine analysis with a payer perspective to compare them.
7. Supervision and review of data at regular intervals.
8. Compilation, data analysis and publication.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between 30-60 years willing to participate in the study.
排除标准
- •Women with previous hysterectomy 2) Previously diagnosed as cervical cancer or precancer lesions.
- •Pregnancy.
结局指标
主要结局
To analyse concordance between first void urine and self collected vaginal sample
时间窗: 2yr
次要结局
- To determine the acceptability of urine testing for cervical cancer screening.(To collect data on the costs associated with implementation of HPV screening by self-sampling and urine analysis with a payer perspective to compare them.)