Cervical Inflammation and Human Papilloma Virus Performance Clinical Trial
Official title:
"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
There is a strong causal association between persisting genital tract infection with Human
Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus)
cancer.The robust study from India have shown that single round of HPV DNA screening test to
significantly reduce the cervical cancer mortality. The above findings are very encouraging
since it demonstrates that a simple and reliable HPV DNA test which is now available in low
income countries has a potential to be accepted as primary screening test in future.
The cross-sectional studies from developed countries from year 1999-2004 which focused to
determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and
higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%.
Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have
focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and
higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average
sensitivity of 79%.Among the developing countries cross-sectional study from India which
evaluated test reported sensitivity of only 68.2%.
There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA
HC2 test between the developed and developing countries to determine CIN2+ Lesions while
there is no difference in the specificity.
A study that was conducted in Chinese women to detected the prevalence of HPV genotype among
women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author
reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis
as compared to other two groups.
So the study will explore if if the presence of untreated co-infections with STIs/RTIs
(Sexually transmitted infections/Reproductive tract infections) resulting in cervical
inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of
blood and excess mucus associated with the conditions leading to low sensitivity of the test
in context to Indian Scenario.
Methodology-The eligible women in the age group of 30-50 years will be screened. Eligibility
criteria will be determined. Women with clinical cervicitis as per NACO guidelines on per
speculum examination will been rolled as cases after signing the inform consent. Women with
no signs and symptoms of cervicitis (No white discharge P/V,No lower Abdominal pain, No
urinary symptoms,No dysperunia,No pruritis vulvae,No post coital bleeding)will be enrolled
as controls after signing the inform consent. The participants ready to participate will be
explained the details and the purpose of the study by Doctor.All the women enrolled in women
shall be followed up after 7-14 days.
Day 1.Cervical swab from ectocervix and endocervix shall be collected. Additional vaginal
swab Will be taken from lateral vaginal wall and posterior fornices for all women enrolled
in study.The swabs will be evenly spread on a glass slide and heat fixed. The slides will be
put in slide box to be transported to Microbiology Department for Gram staining for
Gonococcal, Non-Gonococcal infections,Bacterial Vaginosis,Candida. Next, cervical cells for
HPV DNA testing will be collected.
The women diagnosed with clinical cervicitis will receive treatment on the spot and advised
use to use barrier contraception for 15 days.No treated will be given for the women in
enrolled arm i.e women without clinical and lab STIs.
Day7-14- All the women enrolled in study shall be followed up after 7-14 days. Women will
undergo per-speculum examination and clinical signs of cervicitis or cervicovaginitis will
be reassessed again and documented.
A repeat cervical swab and vaginal swab shall be collected and send for gram staining for
the above mentioned organisms.
A repeat, cervical cells for HPV DNA testing will be collected. Women who are positive for
HPV DNA and STIs on follow up visits shall be counselled and referred for further evaluation
and treatment to appropriate hospital.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening