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.
| Status | Not yet recruiting |
| Enrollment | 508 |
| Est. completion date | July 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 30 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. Sexually active women with clinically diagnosed cervicitis as per NACO guidelines will be enrolled as cases. 2. Sexually active women with no symptoms of STIs/RTIs and clinically no cervicitis will be enrolled as cases. Exclusion Criteria: 1. Pregnant women. 2. Women not willing to follow up. 3. Not willing to use barrier contraception if diagnosed with STIs. 4. Women received antiboitics in last 4 weeks. 5. women with vaginitis without cervicitis on per speculum examination. 6. No drug allergy to the treating drugs. 7. No present or past history of cervical cancer. - |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| India | Tata Memorial Hospital | Mumbai | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Tata Memorial Hospital |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis | 24 months | No |