Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

November 21, 2012 updated by: GlaxoSmithKline

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia

This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

420

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • GSK Investigational Site
      • Riyadh, Saudi Arabia, 11211
        • 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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women >=15 years of age attending out-patient departments of primary, secondary or tertiary care centers for routine cervical screening, in the Kingdom of Saudi Arabia.

Description

Inclusion Criteria:

  • Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
  • Women >=15 years of age attending a clinic for routine cervical screening,
  • Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion Criteria:

  • Referral for abnormal cervical sample at the current visit,
  • Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
  • No cervical sample provided,
  • History of hysterectomy,
  • Known diagnosis of immunosuppression, or patient on immunosuppressives,
  • Pregnant female >=25 years of age.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A
Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.
Other: Data collection
Questionnaire completion
Procedure: Cervical samples
Human papillomavirus detection and typing in cervical samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
Time Frame: At least 12 months from the date of subject enrolment
At least 12 months from the date of subject enrolment

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.
Time Frame: At least 12 months from the date of subject enrolment
At least 12 months from the date of subject enrolment
Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).
Time Frame: At least 12 months from the date of subject enrolment
At least 12 months from the date of subject enrolment
Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.
Time Frame: At least 12 months from the date of subject enrolment
At least 12 months from the date of subject enrolment

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

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111336

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.

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