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

Completed

• Conditions: Human Papillomavirus Infection
• Interventions: Procedure: Endocervical samples

• Registration Number: NCT01158209
• Lead Sponsor: GlaxoSmithKline

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Study Start: 2010-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 490

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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Assessed cohort	Endocervical samples	Subjects attending out-patient health services for gynaecological examination.

Primary Outcome Measures

Name	Time	Method
Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.	Average timeframe: 12 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing	Average timeframe: 12 months
Behavioural risk factors assessed by behavioral questionnaire	At the single study visit (Day 0)
Assessing the awareness of HPV in relation to transmission and cause of cervical cancer	At the single study visit (Day 0)

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇬 Cairo, Egypt