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
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.
Aim (of pilot study):
To evaluate the cell adequacy and smear quality of Pap smears and adequacy of samples for HPV
HC 2 collected before and after application of acetic acid.
Objective of Pilot study-
1. Agreement between the results of HC2 on cervical samples obtained from women before and
5 to 10 mins after VIA test
2. Correlation between RLU/ cutoff ratio of HC2 on cervical samples obtained from women
before and 5 to 10 mins after VIA test.
3. Agreement between the results of cytology on cervical smears obtained immediately before
and 5 to 10 mins after VIA test from the same women.
Methodology:
Design: Pilot study
Study Duration: Three months
Study Site: Preventive Oncology screening clinic, Tata Memorial Hospital
Sample Size calculation and power estimates:
For the pilot study, sampling method is a convenience sample of 50 consecutive eligible women
attending the Preventive Oncology screening clinic and consenting to participate in the
study. These women will be randomly allocated using lottery method (wherein 25 chits with HPV
and 25 chits with cytology written inside will be placed). For every participant woman a chit
will be picked up and the woman will be allotted to either HPV or cytology testing depending
on the message in the chit. Thereafter the chit will be discarded.
In 25 samples Pap smears will be collected before and after application of acetic acid. Steps
mentioned below.
In rest 25 samples HPV DNA will be collected before and after application of acetic acid.
Steps mentioned below.
Step 1: A per speculum examination will be performed on eligible women attending the
Preventive Oncology screening clinic and the findings of the same will be recorded.
Step 2: Pap smear will be collected - Smear 1. OR Cervical cell samples will be collected for
HPV HC II - HPV sample 1. Step 3: VIA will be performed and the findings will be noted. Step
4: A second Pap smear will be collected 5 to 10 minutes after performing VIA when the woman
is still on the examination table by the same provider- Smear 2.
OR Cervical cell samples will be collected for HPV HC II - HPV sample 2. Step 5: The smears
will be submitted to the cytology department for evaluation. The HPV HC II samples will be
submitted to the Microbiology department for evaluation.
Step 6: The cytologist reading the smear will be blinded as to which smear was taken before
and which was taken after the application of acetic acid. The same cytologist will read the
pre-VIA and the post-VIA smears.
Similarly, the Microbiology department staff will be blinded as to which HPV sample was taken
before and which was taken after the application of acetic acid. The paired samples will be
analyzed at the same laboratory in the same batch of testing.
Step 7: The screen negative women will undergo routine follow-up. The screen positive women
will undergo Colposcopy, guided biopsy and further management according to the Tata Memorial
Hospital protocol.
Analysis of the variables Data entry will be done in the Department of Preventive Oncology,
Tata Memorial Hospital using SPSS version 18. Checks for consistency, data safety and
analysis will be carried out at regular intervals. Both descriptive and inferential
statistics will be generated for describing variables under the study objectives. Agreement
in HC2 results between pre-VIA and post-VIA samples will be estimated using kappa statistics.
Similarly, agreement in pap results between pre-VIA and post-VIA samples will be estimated
using kappa statistics. Sensitivity and specificity of HC2 test and pap test in detecting
CIN2+ lesions will be calculated using negative colposcopy or biopsy as the gold standard and
will be compared between the pre and post VIA samples.
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