Cervical Inflammation and Human Papilloma Virus PerformanceNCT02830230
"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
A study testing Tab cefixime,Tab Azithromycin in people with Cervical Inflammation and Human Papilloma Virus Performance, run by Tata Memorial Hospital at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Inflammation and Human Papilloma Virus Performance
- What is being tested?
- Tab cefixime,Tab Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active women with clinically diagnosed cervicitis as per NACO guidelines will be enrolled as cases.
- Sexually active women with no symptoms of STIs/RTIs and clinically no cervicitis will be enrolled as cases.
Who cannot join
- Pregnant women.
- Women not willing to follow up.
- Not willing to use barrier contraception if diagnosed with STIs.
- Women received antiboitics in last 4 weeks.
- women with vaginitis without cervicitis on per speculum examination.
- No drug allergy to the treating drugs.
- No present or past history of cervical cancer. -
Trial locations and contacts
1 site in 1 country.
India1 site
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Sharmila A Pimple, MD, 91-2224154379, drsharmilapatil@yahoo.com
Kavita V Anand, DGO, 9892191968, drkavitaanand@gmail.com
About this study
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%.
Read more
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.
Read the 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.
- Being tested
- Tab cefixime,Tab Azithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab cefixime,Tab AzithromycinDrug
The women with clinical cervicitis will receive treatment for cervicitis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group/Case | Experimental | 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. Receives: Drug: Tab cefixime,Tab Azithromycin |
| Control group | No intervention | Women without signs and symptoms of cervicitis or cervico-vaginitis.No intervention will be done in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Inflammation and Human Papilloma Virus PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Sharmila Pimple, Tata Memorial Hospital
- Investigators
- Reena J Wani, MD, Principal investigator, HBT Medical College & R.N.Cooper Muncipal HospitalSavita R Karnad, M.SC, Principal investigator, HBT Medical College & R.N.Cooper Muncipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830230
- Sponsor's protocol ID
- 1671 RTIs And HPVDNA Test
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"
- ClinicalTrials.gov ID
- NCT02830230
- Acronym / sponsor ID
- 1671 RTIs And HPVDNA Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group/Case | Experimental | Drug: Tab cefixime,Tab Azithromycinwomen 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. |
| Control group | No intervention | –Women without signs and symptoms of cervicitis or cervico-vaginitis.No intervention will be done in this group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sexually active women with clinically diagnosed cervicitis as per NACO guidelines will be enrolled as cases.
- Sexually active women with no symptoms of STIs/RTIs and clinically no cervicitis will be enrolled as cases.
Key exclusion criteria (7 listed)
- Pregnant women.
- Women not willing to follow up.
- Not willing to use barrier contraception if diagnosed with STIs.
- Women received antiboitics in last 4 weeks.
- women with vaginitis without cervicitis on per speculum examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tab cefixime,Tab AzithromycinThe women with clinical cervicitis will receive treatment for cervicitis. | Drug | Intervention group/Case |
Primary outcome
Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Tata Memorial Centre,Mumbai websiateLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reena J Wani, MD principal investigator
HBT Medical College & R.N.Cooper Muncipal Hospital
Savita R Karnad, M.SC principal investigator
HBT Medical College & R.N.Cooper Muncipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tab cefixime,Tab Azithromycin in people with Cervical Inflammation and Human Papilloma Virus Performance, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharmila A Pimple, MD (91-2224154379, drsharmilapatil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the number of participants diagnosed with HPV infections before and after treating clinical cervicitis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.