cervical cancer screening using two methods i.e.Pap smear and visual inspection with acetic acid in a tertiary medical college

Completed

• Conditions: Cervical cancer screening

• Registration Number: CTRI/2021/03/032167
• Lead Sponsor: Dept of Obstetrics and Gynecology M K C G Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-01-07
• Study Start: 2021-03-24
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

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

Inclusion Criteria

1.Female subjects aged between 30-65 years 2.Sexually exposed 3.Not hysterectomized 4.Clearly visible cervix 5.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
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.	12WEEKS

Secondary Outcome Measures

Name	Time	Method
To obtain feedback on VIA based kit testing in the existing healthcare infrastructure.	3MONTHS

Trial Locations

Locations (1)

M K C G Medical College Hospital; 🇮🇳 Ganjam, ORISSA, India

M K C G Medical College Hospital

🇮🇳Ganjam, ORISSA, India

Dr Indira Palo

Principal investigator

9437217544

palo.indira@gmail.com