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

Human Papillomavirus Infection Clinical Trial

Official title:

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 18 Years of Age, in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158209
• Other study ID #: 113367
• Status: Completed
• Phase: N/A
• First received: June 11, 2010
• Last updated: July 12, 2012
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health
• Study type: Observational

Clinical 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Procedure:
• Endocervical samples
Endocervical samples collection during routine gynaecological examinations.

Locations

Country	Name	City	State
Egypt	GSK Investigational Site	Alexandria
Egypt	GSK Investigational Site	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.		Average timeframe: 12 months	No
Secondary	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	No
Secondary	Behavioural risk factors assessed by behavioral questionnaire		At the single study visit (Day 0)	No
Secondary	Assessing the awareness of HPV in relation to transmission and cause of cervical cancer		At the single study visit (Day 0)	No