Infections, PapillomavirusNCT01213459
Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia
An observational study of Infections, Papillomavirus and Cervical Cancer, run by GlaxoSmithKline at 2 sites in Saudi Arabia.
Trial summary
This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Infections, Papillomavirus, Cervical Cancer
- What is being tested?
- Cervical samples and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Apr 2010to Dec 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women >=15 years of age attending out-patient departments of primary, secondary or tertiary care centers for routine cervical screening, in the Kingdom of Saudi Arabia.
Who may be able to join
- Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
- Women >=15 years of age attending a clinic for routine cervical screening,
- Written informed consent obtained from the subject and/or subject's parent/guardian.
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,
- No cervical sample provided,
- History of hysterectomy,
- Known diagnosis of immunosuppression, or patient on immunosuppressives,
- Pregnant female >=25 years of age.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
GSK Investigational Site
Riyadh, 11211
GSK Investigational Site
Riyadh
About this study
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia
This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.
- Conditions
- Infections, Papillomavirus, Cervical Cancer
- Being tested
- Cervical samples, Data collection
- Keywords
- Human papillomavirus
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical samplesProcedure or surgery
Human papillomavirus detection and typing in cervical samples.
Data collectionOther
Questionnaire completion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia. Receives: Procedure: Cervical samples; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
Measured: At least 12 months from the date of subject enrolment
Secondary outcomes (3)
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.
Measured: At least 12 months from the date of subject enrolment
Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).
Measured: At least 12 months from the date of subject enrolment
Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.
Measured: At least 12 months from the date of subject enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 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 Infections, PapillomavirusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 420 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
- NCT01213459
- Sponsor's protocol ID
- 111336
- Status last verified
- Nov 2012
- First submitted
- 1 Oct 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
Publications
AlObaid A, Al-Badawi IA, Al-Kadri H, Gopala K, Kandeil W, Quint W, Al-Aker M, DeAntonio R. Human papillomavirus prevalence and type distribution among women attending routine gynecological examinations in Saudi Arabia. BMC Infect Dis. 2014 Dec 14;14:643. doi: 10.1186/s12879-014-0643-8.
PubMed 25496614
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 >= 15 Years of Age, in the Kingdom of Saudi Arabia
- ClinicalTrials.gov ID
- NCT01213459
- Acronym / sponsor ID
- 111336
- Conditions
- Infections, Papillomavirus, Cervical Cancer
- Keywords
- Human papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Oct 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.
This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Cervical samples, Other: Data collectionWomen ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women >=15 years of age attending out-patient departments of primary, secondary or tertiary care centers for routine cervical screening, in the Kingdom of Saudi Arabia.
Key inclusion criteria (3 listed)
- Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
- Women >=15 years of age attending a clinic for routine cervical screening,
- Written informed consent obtained from the subject and/or subject's parent/guardian.
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,
- No cervical sample provided,
- 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 |
|---|---|---|
| Cervical samplesHuman papillomavirus detection and typing in cervical samples. | Procedure or surgery | Cohort A |
| Data collectionQuestionnaire completion | Other | Cohort A |
Primary outcome
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
Time frame: At least 12 months from the date of subject enrolment
3 secondary outcomes
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.
Time frame: At least 12 months from the date of subject enrolment
Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).
Time frame: At least 12 months from the date of subject enrolment
Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.
Time frame: At least 12 months from the date of subject enrolment
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 25496614AlObaid A, Al-Badawi IA, Al-Kadri H, Gopala K, Kandeil W, Quint W, Al-Aker M, DeAntonio R. Human papillomavirus prevalence and type distribution among women attending routine gynecological examinations in Saudi Arabia. BMC Infect Dis. 2014 Dec 14;14:643. doi: 10.1186/s12879-014-0643-8.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus and Cervical Cancer, run by GlaxoSmithKline at 2 sites in Saudi Arabia.
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 3 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 2 sites in Saudi Arabia. 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 deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening. (time frame: At least 12 months from the date of subject enrolment). 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 NCT01213459, 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.