Pap and HPVDNA Before and After Acetic Acid

NCT02363244 | Completed DMC

• 1 other identifier: 1413 Pap HPV Project
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CIN

Keywords

Pap,HPVDNA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pap group

Per speculum examination will be done.Pap test will be collected for the women as per allotement.A via (visual inspection with acedic acid)test will be done.A repeat cervical cell for pap test will be collected and send to laboratory for further evaluation.

HPVDNA GROUP

Per speculum examination will be done.HPVDNA test will be collected for the women as per allotement.A via (visual inspection with acedic acid)test will be done.A repeat cervical cell for HPVDNA will be collected and send to laboratory for further evaluation.

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy Married women attending the Preventive Oncology screening clinic in the age group 30 to 60 years for cervical cancer screening.

You may qualify if:

• Married women attending the Preventive Oncology screening clinic.
• women in age group 30 to 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Related Links

• Tata Memorial Centre, Mumbai Official website

Biospecimen

Retention: SAMPLES WITH DNA

HPV DNA TEST will be collected in stored as per protocol of storage and will be analysed by hybridisation method in microbiologt Dept of Tata Memorial hospital.

Study Officials

• Gauravi A Mishra,, MD

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dept of Preventive Oncology

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 30, 2018

Record last verified: 2018-04