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临床试验/CTRI/2019/12/022261
CTRI/2019/12/022261已完成不适用

Cervical cancer screening using pap smear and visual inspection with acetic acid in a tertiary care hospital in South India

WESTCHESTER KNOWLEDGEWORKS PVT LTD1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月12日最近更新:

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
To get an understanding on 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 will be designed as 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.

Combining VIA and Pap tests will reduce the number of visits to the hospital, as biopsy can be immediately taken in VIA positive case. In our study we used a ready-to use “kit†instead of preparing 5% acetic acid solution, and procuring each item like glove, speculum etc. separately. This was helpful as we always had the necessary items instead of waiting for availability of 5% acetic acid solution.

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.Sexually exposed 2.Not hysterectomized 3.Clearly visible cervix 4.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

To get an understanding on 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: To get an understanding on 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.

次要结局

  • To obtain feedback on VIA based kit testing in the existing healthcare infrastructure. The feedback of doctors at OPD setting will be recorded using questionnaire.(100 completed)

研究者

发起方
WESTCHESTER KNOWLEDGEWORKS PVT LTD
申办方类型
Other [PVT LTD]

研究点 (1)

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