Human Papillomavirus InfectionNCT01158209
An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline at 2 sites in Egypt.
Trial summary
The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt . Read more about this study
- Who is it for?
- Ages 18 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
- 490 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2010to Aug 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women >= 18 attending out-patient departments of primary, secondary or tertiary care centres for gynaecological examination and agreeing to provide a cervical sample for human papillomavirus testing.
Who may be able to join
- Women >= 18 years of age attending a clinic for gynaecological examination.
- Women who agree to provide a cervical sample for human papillomavirus testing.
- Written 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.
- History of hysterectomy.
- Known diagnosis of immunosuppression, or patient on immunosuppressives.
- Pregnant women.
- Having received one or more doses of HPV vaccine prior to participating in the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 18 Years of Age, in Egypt
The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .
- 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 gynaecological examination. Receives: Procedure: Endocervical samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.
Measured: Average timeframe: 12 months
Secondary outcomes (3)
Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing
Measured: Average timeframe: 12 months
Behavioural risk factors assessed by behavioral questionnaire
Measured: At the single study visit (Day 0)
Assessing the awareness of HPV in relation to transmission and cause of cervical cancer
Measured: At the single study visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 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
- 490 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
- NCT01158209
- Sponsor's protocol ID
- 113367
- Status last verified
- Oct 2011
- First submitted
- 11 Jun 2010
- Last updated
- 16 Jul 2012
- Results posted
- No
Publications
Shaltout MF, Sallam HN, AbouSeeda M, Moiety F, Hemeda H, Ibrahim A, Sherbini ME, Rady H, Gopala K, DeAntonio R. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study. Int J Infect Dis. 2014 Dec;29:226-31. doi: 10.1016/j.ijid.2014.07.029. Epub 2014 Nov 1.
PubMed 25447728
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 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 >= 18 Years of Age, in Egypt
- ClinicalTrials.gov ID
- NCT01158209
- Acronym / sponsor ID
- 113367
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 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 the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .
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 gynaecological examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women >= 18 attending out-patient departments of primary, secondary or tertiary care centres for gynaecological examination and agreeing to provide a cervical sample for human papillomavirus testing.
Key inclusion criteria (3 listed)
- Women >= 18 years of age attending a clinic for gynaecological examination.
- Women who agree to provide a cervical sample for human papillomavirus testing.
- Written 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.
- History of hysterectomy.
- Known diagnosis of immunosuppression, or patient on immunosuppressives.
- Pregnant women.
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
Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.
Time frame: Average timeframe: 12 months
3 secondary outcomes
Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing
Time frame: Average timeframe: 12 months
Behavioural risk factors assessed by behavioral questionnaire
Time frame: At the single study visit (Day 0)
Assessing the awareness of HPV in relation to transmission and cause of cervical cancer
Time frame: At the single study visit (Day 0)
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 16 Jul 2012.
- Derived from this study: PubMed 25447728Shaltout MF, Sallam HN, AbouSeeda M, Moiety F, Hemeda H, Ibrahim A, Sherbini ME, Rady H, Gopala K, DeAntonio R. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study. Int J Infect Dis. 2014 Dec;29:226-31. doi: 10.1016/j.ijid.2014.07.029. Epub 2014 Nov 1.
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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 Human Papillomavirus Infection, run by GlaxoSmithKline at 2 sites in Egypt.
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 16 Jul 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 Egypt. 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?
Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing. (time frame: Average timeframe: 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 NCT01158209, 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 16 Jul 2012.