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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Papillomavirus; Cervical Cancer

Treatments: Other: Data collection; Procedure: Cervical samples

Study type: Observational

Funder types: Industry

Identifiers

NCT01213459

111336

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 1 patient group

Cohort A

Description:

Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.

Treatment:

Procedure: Cervical samples

Other: Data collection