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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213459
• Other study ID #: 111336
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: November 21, 2012
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Saudi Food & Drug Authority (SFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Infections, Papillomavirus
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Cervical samples
Human papillomavirus detection and typing in cervical samples.

Other:
• Data collection
Questionnaire completion

Locations

Country	Name	City	State
Saudi Arabia	GSK Investigational Site	Riyadh
Saudi Arabia	GSK Investigational Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No