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

July 12, 2012 updated by: GlaxoSmithKline

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • GSK Investigational Site
      • Cairo, Egypt
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Assessed cohort
Subjects attending out-patient health services for gynaecological examination.
Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Average timeframe: 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Average timeframe: 12 months
Behavioural risk factors assessed by behavioral questionnaire
Time Frame: At the single study visit (Day 0)
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)
At the single study visit (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Human Papillomavirus Infection

Clinical Trials on Endocervical samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe