Human Papillomavirus InfectionNCT01205412
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline at 1 site in Bahrain.
Trial summary
The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Endocervical samples
- Type of treatment
- Surgery or procedure
- How many people
- 552 participants
- Where
- 1 siteBahrain
- Study dates
- Oct 2010to Nov 2011
- Phase
- Observational
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.
Who may be able to join
- Women ≥ 20 years of age attending a clinic for routine cervical screening OR
- Women ≥ 16 years of age presenting for post-natal check-ups
- Women providing a cervical sample
- Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject
Who cannot join
- Referral for abnormal cervical sample at the current visit
- Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
- Pregnant women
- History of hysterectomy
- Known diagnosis of immunosuppression, or patient on immunosuppressives
- Having received one or more doses of human papillomavirus vaccine prior to participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain
The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Endocervical samples
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocervical samplesProcedure or surgery
Endocervical samples collection during routine gynaecological examinations
| Study group | Role | What they receive |
|---|---|---|
| Assessed Cohort | Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up Receives: Procedure: Endocervical samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
Measured: Average time frame: 12 months
Secondary outcomes (3)
Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.
Measured: Average time frame: 12 months
Behavioural risk factors
Measured: During visit 1 (day 0)
Awareness of HPV in relation to transmission and cause of cervical cancer
Measured: Average time frame: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205412
- Sponsor's protocol ID
- 112710
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
Publications
Moosa K, Alsayyad AS, Quint W, Gopala K, DeAntonio R. An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain. BMC Cancer. 2014 Dec 3;14:905. doi: 10.1186/1471-2407-14-905.
PubMed 25466757
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain
- ClinicalTrials.gov ID
- NCT01205412
- Acronym / sponsor ID
- 112710
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Sep 2010 (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.
The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessed Cohort | – | Procedure: Endocervical samplesSubjects attending out-patient health services for routine cervical screening or presenting for post-natal check up |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.
Key inclusion criteria (4 listed)
- Women ≥ 20 years of age attending a clinic for routine cervical screening OR
- Women ≥ 16 years of age presenting for post-natal check-ups
- Women providing a cervical sample
- Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject
Key exclusion criteria (6 listed)
- Referral for abnormal cervical sample at the current visit
- Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
- Pregnant women
- History of hysterectomy
- Known diagnosis of immunosuppression, or patient on immunosuppressives
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 |
|---|---|---|
| Endocervical samplesEndocervical samples collection during routine gynaecological examinations | Procedure or surgery | Assessed Cohort |
Primary outcome
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
Time frame: Average time frame: 12 months
3 secondary outcomes
Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.
Time frame: Average time frame: 12 months
Behavioural risk factors
Time frame: During visit 1 (day 0)
Awareness of HPV in relation to transmission and cause of cervical cancer
Time frame: Average time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Derived from this study: PubMed 25466757Moosa K, Alsayyad AS, Quint W, Gopala K, DeAntonio R. An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain. BMC Cancer. 2014 Dec 3;14:905. doi: 10.1186/1471-2407-14-905.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline at 1 site in Bahrain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Nov 2012. 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 Bahrain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up. (time frame: Average time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205412, which also lists 1 linked publication.
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 22 Nov 2012.