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"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"

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ClinicalTrials.gov Identifier: NCT02830230
Recruitment Status : Unknown
Verified July 2016 by Dr Sharmila Pimple, Tata Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Sharmila Pimple, Tata Memorial Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cervical Inflammation and Human Papilloma Virus Performance Drug: Tab cefixime,Tab Azithromycin Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: "Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group/Case

women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group.

women with clinical cervicitis or cervicovaginitis as per NACO Guidelines will be enrolled in intervention group.A cervico-vaginal swab shall be taken for Lab diagnosis of RTIs along with HPVDNA test on day 1.Women shall be treated with Tab Azithromycin 1gm and Tab Cefixime 400mg stat along with barrier contraception advised.The women will be followed up after 7-14 days .A repeat cervicovaginal swab and HPVDNA shall be repeated.

Drug: Tab cefixime,Tab Azithromycin
The women with clinical cervicitis will receive treatment for cervicitis.

No Intervention: Control group
Women without signs and symptoms of cervicitis or cervico-vaginitis.No intervention will be done in this group



Primary Outcome Measures :
  1. Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830230


Contacts
Contact: Sharmila A Pimple, MD 91-2224154379 drsharmilapatil@yahoo.com
Contact: Kavita V Anand, DGO 9892191968 drkavitaanand@gmail.com

Locations
India
Tata Memorial Hospital Not yet recruiting
Mumbai, Maharashtra, India, 400012
Contact: Sharmila A Pimple, MD    91-2224154379    drsharmilapatil@yahoo.com   
Contact: Kavita V Anand, DGO    9892191968    drkavitaanand@gmail.com   
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Reena J Wani, MD HBT Medical College & R.N.Cooper Muncipal Hospital
Principal Investigator: Savita R Karnad, M.SC HBT Medical College & R.N.Cooper Muncipal Hospital

Additional Information:
Responsible Party: Dr Sharmila Pimple, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02830230     History of Changes
Other Study ID Numbers: 1671 RTIs And HPVDNA Test
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Papilloma
Coinfection
Pathologic Processes
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Virus Diseases
Parasitic Diseases
Cefixime
Anti-Bacterial Agents
Anti-Infective Agents