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

Completed

• Conditions: Infections, Papillomavirus; Cervical Cancer
• Interventions: Procedure: Cervical samples; Other: Data collection

• Registration Number: NCT01213459
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Cervical samples	Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.
Cohort A	Data collection	Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.	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).	At least 12 months from the date of subject enrolment

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇦 Riyadh, Saudi Arabia