Operationalizing cervical cancer screening using pap smear and visual inspection with acetic acid in a tertiary care hospital in East India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- conducting cervical cancer screening in outpatient center by Gynecologist using naked eye VIA based method. And compare the results of VIA based detection with Pap smear results.
研究概览
简要总结
The clinical investigation is designed as an observational study, because it is being conducted primarily to understand the implementation of VIA based screening in outpatient setting. Women who satisfy the inclusion criteria and are willing to sign the consent form will be enrolled for the study. PI will recruit the female subjects and will examine them as per routine protocol for cervical cancer screening in the hospital. In addition, they will perform visual inspection with acetic acid. Subject’s brief history and examination findings will be recorded in CRF. Pap smear results for each case will be collected when ready and results entered in the CRF. Cervical biopsy will be done for screening positive patients. At the end of the study the results will be compiled for all the cases and analysis will be done.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female subjects aged between 30-65 years 2.Sexually exposed 3.Not hysterectomized 4.Clearly visible cervix 5.Willing to sign consent form.
排除标准
- •1.Consent not available 2.Age <30 years 3.Sexually unexposed 4.No cervix/ cervix not visible.
结局指标
主要结局
conducting cervical cancer screening in outpatient center by Gynecologist using naked eye VIA based method. And compare the results of VIA based detection with Pap smear results.
时间窗: 12WEEKS
次要结局
- To obtain feedback on VIA based kit testing in the existing healthcare infrastructure.(3MONTHS)