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CompletedNCT01158209Updated Jul 16, 2012

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

An observational study in Human Papillomavirus Infection, sponsored by GlaxoSmithKline. Completed at 2 sites in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-16.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
490
Ages
18 Years and older
Sex
Female
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Study 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 .

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Conditions studied

  • Human Papillomavirus Infection
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In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 490 is above the median of 400 across 147 observational studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
490 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Assessed cohort

    Subjects attending out-patient health services for gynaecological examination.

    Procedure: Endocervical samples

Interventions

  • ProcedureEndocervical samples

    Endocervical samples collection during routine gynaecological examinations.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Behavioural risk factors assessed by behavioral questionnaire

    Time frame: At the single study visit (Day 0)

  3. Assessing the awareness of HPV in relation to transmission and cause of cervical cancer

    Time frame: At the single study visit (Day 0)

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Study locations

2 sites
  • GSK Investigational Site
    Alexandria, Egypt
  • GSK Investigational Site
    Cairo, Egypt
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01158209
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 8, 2010
Start date
Oct 2010
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Jul 16, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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