Comparision of two methods of cervical cancer screening i.e. cell based method(papsmear) and naked eye examination after applying like vinegar(VIA).

Completed

• Conditions: Cervical Cancer Screening

• Registration Number: CTRI/2019/12/022261
• Lead Sponsor: WESTCHESTER KNOWLEDGEWORKS PVT LTD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-12
• Study Completion: 2020-06-19
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Sexually exposed 2.Not hysterectomized 3.Clearly visible cervix 4.Willing to sign consent form.

Exclusion Criteria

1.Consent not available 2.Age <30 years 3.Sexually unexposed 4.No cervix/ cervix not visible.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Kempegowda Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Hethyshi Ranganna

Principal investigator

9535592250

hethyshi@gmail.com