CIN Clinical Trial
Official title:
A Pilot Study on Comparative Evaluation of Results of Pap Smears and HPV Hybrid Capture 2 Performed on Cervical Samples Before and After Application of Acetic Acid
NCT number | NCT02363244 |
Other study ID # | 1413 Pap HPV Project |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | December 2015 |
Verified date | April 2018 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a pilot study to assess the cell adequacy and quality of Pap smears and adequacy of samples for HPV DNA virus test done after application of 5%acetic acid in a VIA test.Normally a Pap test and HPV DNA test is performed before application of acetic acid. It is assumed that application of acetic acid may alter the cell adequacy of Pap test and HPV DNA test, if any of the above tests is done immediately after VIA test.The present study aims to see the effect of 4-5% acetic acid [vinegar] on the cell adequacy and quality of Pap smear and sample adequacy for HPV DNA test.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Married women attending the Preventive Oncology screening clinic. - women in age group 30 to 60 years Exclusion Criteria - Unmarried women - married women in the age group less than 30 years and above 60 years - pregnant women - women with history of total hysterectomy - women with cervical cancer |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparative Evaluation Of Results Of Pap Smears And HPV Hybrid Capture 2 Performed On Cervical Samples Before And After Application Of Acetic Acid. | The purpose of this pilot study is to assess the cell adequacy and quality of Pap smears and adequacy of samples for HPV DNA virus test done after application of acetic acid. | 3 months |
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