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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer, Infections, Papillomavirus

Intervention / Treatment
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* Procedure: Cervical samples
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | At least 12 months from the date of subject enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papillomavirus